The Effect of Preemptive Perianal Ropivacaine and Ropivacaine with Dexmedetomidine on Pain after Hemorrhoidectomy: A Prospective,Randomized, Double-Blind,Placebo-Controlled Study

The objective of this study was to assess the efficacy of perianal infiltration of ropivacaine and dexmedetomidine added to ropivacainein in the relief of pain after hemorrhoidectomy. Patients in group C(placebo control group, n = 21) received perianal injections of normal saline and those in group RO(ropivacaine injection group, n = 21) received ropivacaine, those in group RD(ropivacaine with dexmedetomidine injection group, n = 19) were administered ropivacaine with dexmedetomidine, prior to the initiation of the operation. Reductions of the VAS score, the frequency with which the PCA button was pushed, and fentanyl consumption were assessed in groups RO and RD as compared to that of group C, and in group RD as compared to that of group RO(p < 0.05). We concluded that the use of perianal ropivacaine injection prior to surgical incision reduced both postoperative pain and fentanyl consumption following hemorrhoidectomy, and the addition of dexmedetomidine to ropivacaine may have an additive effect in postoperative analgesic care.     

Oral ketamine and dexmedetomidine in adults’ burns wound dressing—A randomized double blind cross over study

Study was designed to compare analgesic efficacy and side effects of oral dexmedetomidine and ketamine in adults for burn wound dressing.     

Intrathecal Ropivacaine for Ambulatory Surgery: A Comparison between Intrathecal Bupivacaine and Intrathecal Ropivacaine for Knee Arthroscopy

Background: The rationale of this study was to evaluate intrathecal ropivacaine for ambulatory surgery.

Methods: One hundred fifty patients with American Society of Anesthesiologists physical status 1 scheduled for knee arthroscopy were studied. Patients were randomly assigned to receive 4 ml of one of five isobaric intrathecal solutions: Patients in group 1 (n = 30) received 8 mg of bupivacaine; patients in group 2 (n = 30) received 8 mg ropivacaine; patients in group 3 (n = 30) received 10 mg ropivacaine; patients in group 4 (n = 30) received 12 mg ropivacaine; and patients in group 5 (n = 30) received 14 mg ropivacaine. The level and duration of sensory anesthesia were recorded along with the intensity and duration of motor block. Patients were interviewed to identify transient neurologic symptoms.

Results: Intrathecal ropivacaine 10 mg produced shorter sensory anesthesia and motor blockade than bupivacaine 8mg (152 +/- 44 min and 135 +/- 41 min vs. 181 +/- 44 min and 169 +/- 52 min, mean +/- SD;P < 0.05). However, the quality of intraoperative analgesia was significantly lower in the 10-mg ropivacaine group (P < 0.05). Ropivacaine 12 mg produced sensory and motor block almost comparable to bupivacaine 8 mg. Ropivacaine 14 mg produced sensory and motor block comparable to ropivacaine 12 mg but significantly increased the time to void. No sign of transient radicular irritation were noted.     

Efficacy and Safety of Hyaluronic Acid Intra‐articular Injection after Arthroscopic Knee Surgery: A Systematic Review and Meta‐analysis

ObjectiveHyaluronic acid (HA) intra‐articular injection after arthroscopic knee surgery has been widely applied but its efficacy and safety remain controversial. The aim of this systematic review is to analyze the efficacy and safety of HA intra‐articular injection after arthroscopic knee surgery, and to compare the efficacy of HA with different molecular weights.MethodsWe conducted a systematic literature search in PubMed, Embase, Google scholar and the Cochrane library from inception to 16 September 2022 for English‐written articles, in order to identify randomized controlled trials that evaluated the clinical efficacy and/or safety of HA intra‐articular injection after arthroscopic knee surgery. Then we meta‐analyzed the outcomes of patients given intra‐articular HA injections postoperatively and control patients. We also evaluated the influence of HA with different molecular weights. In every calculation, sensitive analysis was performed. The visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and adverse events were selected as the primary outcome measurements, while Lysholm, International Knee Documentation Committee (IKDC) and Tegner score were selected as the secondary outcome measurements. Publication bias of every outcome was evaluated using egger test.ResultsFifteen studies involving 951 knees were included and 12 of them were used to performed the meta‐analysis. The results showed no significant difference between the HA group and control group according to VAS, whether assessed at less (P = 0.90) or more than 6 months (P = 0.55). Besides, there were no statistical differences between the HA group and control group according to subgroup analysis (Ps = 0.77, 0.91 and 0.81 in anterior cruciate ligament reconstruction, meniscectomy and overall groups, respectively). Compared to control group, the overall effect of WOMAC score showed no significant differences (P = 0.25), nor did in two subgroups (P = 0.37 and P = 0.22). Outcomes measured by Lysholm (P = 0.13), IKDC (P = 0.86) and Tegner (P = 0.42) scores showed no significant differences, either. The analysis of the risk of adverse events indicated no increase in HA groups (P = 0.06). We found no significant differences between high‐ and low‐molecular‐weight HA at 6 (P = 0.96) or 12 months (P = 0.93) postoperatively. Two studies failed to pass the sensitive analysis and the reasons were discussed detailly and acceptable publication bias was observed.ConclusionsAlthough HA injection after arthroscopic knee surgery is safe, the available evidence does not support its efficacy in pain relief and functional recovery. Therefore, the application of HA injection after arthroscopic knee surgery is not recommended.     

A Double‐Blind,Double‐Dummy,Flexible‐Design Randomized Multicenter Trial: Early Safety of Single‐ Versus Divided‐Dose Rabbit Anti‐Thymocyte Globulin Induction in Renal Transplantation

A previous nonblinded, randomized, single‐center renal transplantation trial of single‐dose rabbit anti‐thymocyte globulin induction (SD‐rATG) showed improved efficacy compared with conventional divided‐dose (DD‐rATG) administration. The present multicenter, double‐blind/double‐dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD‐rATG versus DD‐rATG induction for noninferiority in early (7‐day) safety and tolerability. Ninety‐five patients (randomized 1:1) received 6 mg/kg SD‐rATG or 1.5 mg/kg/dose DD‐rATG, with tacrolimus‐mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12‐month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD‐rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD‐rATG induction to be noninferior to DD‐rATG induction in early tolerability and equivalent in 12‐month safety. (Clinical Trials.gov #NCT00906204.)     

Dexmedetomidine Prolongs the Analgesic Effects of Periarticular Infiltration Analgesia following Total Knee Arthroplasty: A Prospective,Double-Blind,Randomized Controlled Trial

BackgroundPeriarticular infiltration analgesia (PIA) is widely administered to relieve postoperative pain following total knee arthroplasty (TKA). The present study aimed to evaluate the effect of prolonging the analgesic duration by adding dexmedetomidine to PIA for pain management after TKA.MethodsOne hundred and sixteen patients were randomly allocated into 3 groups based on PIA regimens including group R (ropivacaine), group E (ropivacaine plus epinephrine), and group D (ropivacaine plus dexmedetomidine). The primary outcomes were postoperative visual analog scale scores, time until the administration of first rescue analgesia, and opioid consumption. The secondary outcomes included postoperative inflammatory biomarkers and functional recovery. The tertiary outcomes were postoperative complications and adverse events.ResultsThe patients in group D had significantly lower resting visual analog scale scores than those in groups R and E at 6 hours after surgery. Group R showed the higher pain scores at rest and motion than groups D and E 12 hours postoperatively. The use of dexmedetomidine or epinephrine postponed the time until the administration of first rescue analgesia and led to lower opioid consumption in the first 24 hours after TKA. The levels of interleukin-8 and tumor necrosis factor-α in groups D and E were significantly lower than those in group R on postoperative day 3. Furthermore, no significant differences were observed in functional recovery, postoperative complications, or adverse events among the three groups.ConclusionsAdding dexmedetomidine as an adjuvant to PIA could potentiate and prolong the analgesic effect in the early stage following TKA without increasing the risk of adverse events.     

Combination of Intravenous and Intra‐Articular Application of Tranexamic Acid and Epsilon‐Aminocaproic Acid in Primary Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

ObjectiveThere were limited randomized controlled trials (RCTs) of epsilon‐aminocaproic acid (EACA) versus tranexamic acid (TXA) in total knee arthroplasty (TKA). The aim of the study was to compare the efficacy and safety of TXA and EACA in the combination of intravenous (IV) and intra‐articular (IA) administration on reducing blood loss in patients following primary TKA.MethodsFrom January 2020 to January 2021, a total of 181 patients undergoing a primary unilateral TKA were enrolled in this prospective randomized controlled trial. Patients in the TXA group (n = 90) received 20 mg/kg of intravenous TXA preoperatively, 1 g of intra‐articular TXA intraoperatively, and three doses of 20 mg/kg intravenous TXA at 0, 3, 6 h postoperatively. Patients in the EACA group (n = 91) received 120 mg/kg of intravenous EACA preoperatively, 2 g of intra‐articular EACA intraoperatively, and three doses of 40 mg/kg intravenous EACA at 0, 3, 6 h postoperatively. The primary outcomes were total blood loss (TBL), transfusion rates and drop of hemoglobin (HB) level. The secondary outcomes included postoperative hospital stays and postoperative complications. The chi‐square tests and Fisher''s exact tests were utilized to compare categorical variables, while the independent‐samples t‐tests and Mann–Whitney tests were used to compare continuous variables.ResultsThe patients who received TXA averaged less TBL than the patients who received EACA (831.83 ml vs 1065.49 ml, P = 0.015), and HB drop in TXA group was generally less than that of EACA group on postoperative day 1 and 3 (20.84 ± 9.48 g/L vs 24.99 ± 9.40 g/L, P = 0.004; 31.28 ± 11.19 vs 35.46 ± 12.26 g/L, P = 0.047). The length of postoperative stays in EACA group was 3.66 ± 0.81 day, which is longer than 2.62 ± 0.68 day in TXA group (P < 0.001). No transfusions were required in either group. The risk of nausea and vomiting in TXA group was significantly higher than that in EACA group (11/90 vs 0/91, P < 0.01).ConclusionAlthough the TBL and HB drop were slightly greater in EACA group, these results were not clinically important, given that no transfusions were required. EACA could be an alternative to TXA, especially for patients with severe nausea and vomiting after using TXA postoperatively. Further studies are needed to adjust dosage of EACA to make better comparison of the two drugs.     

Comparison between Ultrasound-Guided Pericapsular Nerve Group Block and Local Infiltration Analgesia for Postoperative Analgesia after Total Hip Arthroplasty: A Prospective Randomized Controlled Trial

Objectives

Pericapsular nerve group (PENG) blocking is a novel nerve block modality for analgesia after total hip arthroplasty (THA); however, its analgesic efficacy is unclear. We aimed to compare the analgesic effect of ultrasound-guided PENG blocking and periarticular local infiltration analgesia after THA.

Methods

This study involved patients undergoing unilateral primary THA at our institution between October 2022 and December 2022. Based on a prospective double-blind, randomized approach, patients were randomly divided into two groups: the PENG and infiltration groups. The former received ultrasound-guided pericapsular nerve block before surgery while the latter received local anesthesia and local infiltration analgesia during surgery. The primary outcome was the amount of morphine used for rescue analgesia within 48 h after surgery and the visual analog scale (VAS) pain score at 3, 6, 12, 24, and 48 h after surgery. Secondary outcomes consisted of postoperative hip function on the first and second postoperative days, including hip extension angle and flexion, as well as distance traveled by the patient. Tertiary outcomes included length of hospital stay and postoperative adverse reactions. The data were analyzed using SPSS 26.0. Using the appropriate statistical methodology, continuous and categorical data were analyzed, and p < 0.05 was considered statistically significant.

Results

There was no clear difference in morphine requirements during the first 24 hours postoperatively (5.8 ± 5.9 vs. 6.0 ± 6.3, p = 0.910), in the total postoperative morphine consumption (7.5 ± 6.3 vs. 7.8 ± 6.6, p = 0.889), and in the postoperative resting VAS pain scores (p > 0.05). However, the exercise VAS score in the PENG group was significantly higher than that in the infiltration group within 12 hours after surgery (6.1 + 1.2 vs. 5.4 + 1.0, p = 0.008). There was no significant difference in hip function, length of hospital stay, or incidence of complications between the two groups.

Conclusion

The analgesic effect and functional recovery of ultrasound-guided pericapsular nerve block for THA was not superior to that of periarticular local infiltration analgesia.     

Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter,Randomized, Double‐Blind,Placebo‐Controlled Trial

We hypothesized that preemptive fibrinogen administration to obtain an initial plasma level of 2.9 g/L would reduce transfusion requirements in liver transplantation. A randomized, multicenter, hemoglobin‐stratified, double‐blind, fibrinogen‐versus‐saline–controlled trial was conducted. The primary end point was the percentage of patients requiring red blood cells. We evaluated 51 patients allocated to fibrinogen and 48 allocated to saline; the primary end point was assessed using data for 92 patients because the electronic record forms were offline for three patients in the fibrinogen group and four in the saline group. We injected a median of 3.54 g fibrinogen preemptively in the fibrinogen group. Nine patients in the saline group (20.9%) required fibrinogen at graft reperfusion (compared with one patient [2.1%] in the fibrinogen group; p = 0.005). Blood was transfused to 52.9% (95% confidence interval [CI] 42.5–63.3%) in the fibrinogen group and 42.74% (95% CI 28.3–57.2%) in the saline group (p = 0.217). Relative risk for blood transfusion was 0.80 (95% CI 0.57–1.13). Thrombotic events occurred in one patient (2.1%) and five patients (11.4%) in the fibrinogen and saline groups, respectively. Seven patients (14.6%) in the fibrinogen group and nine (20.3%) in the saline group required reoperation. Preemptive administration of fibrinogen concentrate did not influence transfusion requirements.     

Outcome of HCV/HIV‐Coinfected Liver Transplant Recipients: A Prospective and Multicenter Cohort Study

Eighty‐four HCV/HIV‐coinfected and 252‐matched HCV‐monoinfected liver transplant recipients were included in a prospective multicenter study. Thirty‐six (43%) HCV/HIV‐coinfected and 75 (30%) HCV‐monoinfected patients died, with a survival rate at 5 years of 54% (95% CI, 42–64) and 71% (95% CI, 66 to 77; p = 0.008), respectively. When both groups were considered together, HIV infection was an independent predictor of mortality (HR, 2.202; 95% CI, 1.420–3.413 [p < 0.001]). Multivariate analysis of only the HCV/HIV‐coinfected recipients, revealed HCV genotype 1 (HR, 2.98; 95% CI, 1.32–6.76), donor risk index (HR, 9.48; 95% CI, 2.75–32.73) and negative plasma HCV RNA (HR, 0.14; 95% CI, 0.03–0.62) to be associated with mortality. When this analysis was restricted to pretransplant variables, we identified three independent factors (HCV genotype 1, pretransplant MELD score and centers with <1 liver transplantation/year in HIV‐infected patients) that allowed us to identify a subset of 60 (71%) patients with a similar 5‐year prognosis (69%[95% CI, 54–80]) to that of HCV‐monoinfected recipients. In conclusion, 5‐year survival in HCV/HIV‐coinfected liver recipients was lower than in HCV‐monoinfected recipients, although an important subset with a favorable prognosis was identified in the former.     

Comparison of Efficacy of Adductor Canal Block,Local Infiltration Analgesia and Both Combined in Postoperative Pain Management After Total Knee Arthroplasty: A Randomized Controlled Trial

PurposeThe aim of our study is to compare the efficacy of adductor canal block (ACB), periarticular local infiltration (PLI) and both combined (ACB + PLI) in multimodal pain management after TKA.MethodsThis is a prospective, randomized controlled double-blinded study undergoing primary unilateral TKA. They were randomized into three groups with fifty patients in each group: ACB alone (30 ml of 0.2% ropivacaine), PLI alone (30 ml 0.5% ropivacaine in 20 ml of normal saline), and both combined (ACB + PLI). The primary outcome studied was pain using visual analog score (VAS) in postoperative days (POD) 1 and 2. The secondary outcomes estimated were the ambulation capacity, the knee range of motion, need for rescue analgesia and length of hospital stay.ResultsThe mean VAS score was significantly lower at rest and after mobilization in the combined group (3.51 at POD 1, 2.04 at POD 2), compared with either alone group (ACB = 4.70, 2.86 versus PLI = 4.39, 3.41 at POD 1 and 2 respectively after mobilization, p < 0.001). The ambulation capacity (combined = 103.3 steps versus ACB = 98.1 and PLI = 95.2 steps, p = 0.04) and the knee range of motion (arc of motion 106.7 degrees versus ACB = 104.9 and PLI = 102.2 degrees, p = 0.004) were significantly higher in the combined group compared to the other groups. There was no significant difference in the length of stay between the groups (p = 0.12).ConclusionAdductor canal block combined with periarticular local infiltration provides better pain relief, good range of motion, quicker rehabilitation, and reduced opioid consumption.     

Ibandronate Prevents Bone Loss and Reduces Vertebral Fracture Risk in Male Cardiac Transplant Patients: A Randomized Double‐Blind,Placebo‐Controlled Trial

Bone loss and fractures are common complications after cardiac transplantation (CTP). The aim of this study was to investigate whether intravenous ibandronate is an effective preventive option. Thirty‐five male cardiac transplant recipients received either ibandronate (IBN) 2 mg intravenously every 3 mo or matching placebo (CTR) in addition to 500 mg calcium carbonate and 400 IE vitamin D₃. Sera were collected at CTP and every 3 mo thereafter. At baseline and 6 and 12 mo, standardized spinal X‐rays and BMD measurements were taken. Bone biopsies were taken at CTP and after 6 mo from six patients. In the IBN group, 13% of the patients sustained a new morphometric vertebral fracture compared with 53% in the CTR group (absolute risk reduction [ARR], 40%; relative risk reduction [RRR], 75%; p = 0.04). BMD remained unchanged with IBN treatment but in the CTR group decreased at the lumbar spine by 25% and at the femoral neck by 23% (both p < 0.0001) over the 1‐yr period. Serum bone resorption markers carboxy‐terminal telopeptide region of type I collagen (sCTX) and TRACP 5b were significantly increased in the CTR group and decreased in the IBN group at all time points compared with baseline. In contrast, both osteocalcin and bone‐specific alkaline phosphatase levels showed, after a similar decrease over the first 3 mo in both groups, a marked rise in the CTR subjects and steadily declining levels in the IBN patients throughout the remainder of the study period. Three paired biopsies were available from each group. Despite the small sample size, a difference in the relative change of eroded surface (68% in the CTR versus ?23% in the IBN group, p < 0.05) could be shown. Intravenous IBN reduced fractures, preserved bone mass, and prevented uncoupling of bone formation and resorption after CTP. The favorable effects on bone turnover were also supported by histomorphometric findings.     

Systematic Review and Meta-Analysis of Intrawound Vancomycin in Total Hip and Total Knee Arthroplasty: A Continued Call for a Prospective Randomized Trial

BackgroundPeriprosthetic joint injection (PJI) is a rare, but life-altering complication of total joint arthroplasty (TJA). Though intrawound vancomycin powder (IVP) has been studied in other orthopedic subspecialties, its efficacy and safety in TJA has not been established.MethodsPubMed and MEDLINE databases were used to identify studies utilizing IVP in primary and revision total hip (THA) and knee arthroplasty (TKA). Postoperative PJI data were pooled using random effect models with results reported as odds ratios (ORs) and 95% confidence intervals (CIs). Studies were weighted by the inverse variance of their effect estimates.ResultsOverall, 16 of the 1871 studies identified were pooled for final analysis, yielding 33,731 patients totally. Of these, 17 164 received IVP. In aggregate, patients who received IVP had a decreased rate of PJI (OR 0.46, P < .05). Separately, TKA and THA patients who received IVP had lower rates of PJI (OR 0.41, P < .05 and OR 0.45, P < .05, respectively). Aggregate analysis of primary TKA and THA patients also revealed a decreased PJI rate (OR 0.44, P < .05). Pooled revision TKA and THA patients had a similar decrease in PJI rates (OR 0.30, P < .05). Although no publication bias was appreciated, these findings are limited by the low-quality evidence available.ConclusionWhile IVP may reduce the risk of PJI in primary and revision TJA, its widespread use cannot be recommended until higher-quality data, such as that obtained from randomized control trials, are available. This study underscores the continued need for more rigorous studies before general adoption of this practice by arthroplasty surgeons.     

Efficacy and Safety of Maribavir Dosed at 100 mg Orally Twice Daily for the Prevention of Cytomegalovirus Disease in Liver Transplant Recipients: A Randomized,Double‐Blind,Multicenter Controlled Trial

Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double‐blind, multicenter trial, the efficacy and safety of prophylactic oral maribavir (100 mg twice daily) for prevention of CMV disease were compared with oral ganciclovir (1000 mg three times daily) in 303 CMV‐seronegative liver transplant recipients with CMV‐seropositive donors (147 maribavir; 156 ganciclovir). Patients received study drug for up to 14 weeks and were monitored for CMV infection by blood surveillance tests and also for the development of CMV disease. The primary endpoint was Endpoint Committee (EC)‐confirmed CMV disease within 6 months of transplantation. In a modified intent‐to‐treat analysis, the noninferiority of maribavir compared to oral ganciclovir for prevention of CMV disease was not established (12% with maribavir vs. 8% with ganciclovir: event rate difference of 0.041; 95% CI: ?0.038, 0.119). Furthermore, significantly fewer ganciclovir patients had EC‐confirmed CMV disease or CMV infection by pp65 antigenemia or CMV DNA PCR compared to maribavir patients at both 100 days (20% vs. 60%; p < 0.0001) and at 6 months (53% vs. 72%; p = 0.0053) after transplantation. Graft rejection, patient survival, and non‐CMV infections were similar for maribavir and ganciclovir patients. Maribavir was well‐tolerated and associated with fewer hematological adverse events than oral ganciclovir. At a dose of 100 mg twice daily, maribavir is safe but not adequate for prevention of CMV disease in liver transplant recipients at high risk for CMV disease.     

Complete Steroid Avoidance Is Effective and Safe in Children With Renal Transplants: A Multicenter Randomized Trial With Three‐Year Follow‐Up

To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid‐free (SF) or steroid‐based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow‐up was 3 years posttransplant. Standardized height Z‐score change after 3 years follow‐up was –0.99 ± 2.20 in SF versus –0.93 ± 1.11 in SB; p = 0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z‐score at 3 years –0.43 ± 1.15 vs. –1.07 ± 1.14; p = 0.019). There were no differences in the rates of biopsy‐proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p = 0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p = 0.30) at 3 years follow‐up. Over the 3 year follow‐up period, the SF group showed lower systolic BP (p = 0.017) and lower cholesterol levels (p = 0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.