Prospective randomized,double-blinded,placebo-controlled trial of preoperative etoricoxib for pain relief in uterine fractional curettage under paracervical block

Objective

To evaluate the analgesic efficacy of preoperative etoricoxib combined with paracervical nerve block in patients who underwent uterine fractional curettage.

Study design

This double-blinded, randomized, placebo-controlled trial included 80 women who underwent uterine fractional curettage under paracervical block. Forty women were randomly assigned to etoricoxib 120 mg and 40 women to the placebo. The main outcome measure was the intensity of pain measured using the visual analog pain score during and after the procedure. Student's t-tests, Mann–Whitney U-test, and Chi-squared test were used for statistical analysis.

Results

The intensity of pain during operative procedure in the etoricoxib group was lower than in the placebo group (median visual analog pain scores (interquartile range) 48 (43–64) vs. 61 (51–72), P = 0.001) The amount of postoperative acetaminophen used in the etoricoxib group was also lower than in the placebo group (2.2 ± 1.7 vs. 3.2 ± 1.7 tablets, P = 0.011). We found no significant adverse effects in this study.

Conclusion

The preoperative administration of 120 mg oral etoricoxib can slightly reduce pain during fractional curettage under paracervical block. However, the degree of pain reduction by this treatment has no clinical importance.     

Lidocaine versus plain saline for pain relief in fractional curettage: a randomized controlled trial

OBJECTIVE: To compare the efficiency of lidocaine with that of plain saline for paracervical pain relief during fractional curettage. METHODS: This double-blind, randomized, controlled trial included 140 women who underwent fractional curettage. Seventy women were allocated to the lidocaine group and 70 to the plain saline group. The main outcome measure was the intensity of pain measured by visual analog scale during and after the procedure. RESULTS: The intensity of pain was significantly lower in the lidocaine group than in the plain saline group over the course of the procedure (P = .02), especially during fractional curettage. There were no serious adverse effects in this study. CONCLUSION: Lidocaine is more effective than plain saline for paracervical pain relief during fractional curettage. The anesthetic mechanisms of lidocaine are mechanical distention of tissue and peripheral nerve block.     

Pretreatment bowel manipulation during ultrasound-guided high-intensity focused ultrasound therapy for posterior wall uterine masses

ObjectiveHigh-intensity focused ultrasound (HIFU) therapy is a noninvasive alternative to conventional abdominal surgery in obstetrics and gynecology. The aim of this study is to evaluate the reduction of pain intensity with bowel manipulation before ultrasound-guided HIFU treatment in women with posterior wall uterine fibroids and/or adenomyosis.Materials and methodsThis is a multicenter retrospective observational study. Data from all patients who underwent HIFU therapy at three HIFU clinics (Sichuan Maternal and Child Health Hospital, Xiangya Hospital of Central South University, and Kuo General Hospital) between January 2019 and December 2019 were analyzed. We compared pain intensity with and without bowel manipulation during the HIFU treatment and evaluated tolerability without intravenous sedation. The presence of discomfort or pain during the HIFU procedure was evaluated using the visual analog scale (VAS).ResultsA total of 86 women were included in this study. All women underwent HIFU therapy with the PRO-2008 system in the supine position for posterior wall uterine fibroids and/or adenomyosis. Thirty-seven women received pretreatment anal catheterization with a condom and 49 women were not subjected to bowel manipulation. All patients received pretreatment condom-catheter device were well tolerated during the procedure of bowel manipulation. During the HIFU procedure, the women who had received bowel manipulation experienced lower pain intensity, especially less sacrococcygeal pain (VAS score 1.56 ± 1.46 vs 2.89 ± 1.61), target region pain (1.54 ± 1.30 vs 2.53 ± 1.29), and radiating pain (0.13 ± 0.34 vs 0.41 ± 0.54), compared with the women without bowel manipulation.ConclusionBowel manipulation with anal catheterization before HIFU therapy for posterior wall uterine masses can be safely performed and is effective as a low risk intervention to aid in reducing potential HIFU complications related to nerve involvement.     

Visual analog scale pain score after laparoscopic tubal sterilization: comparison of micro-laparoscopy and conventional technique

The objective of this study was to compare pain status after microlaparoscopic tubal sterilization under local anesthesia with mild sedation and after conventional laparoscopic tubal sterilization under general anesthesia. Between March 2003 and January 2004, 100 women undergoing laparoscopic tubal sterilization were equally and prospectively divided into two groups: microlaparoscopy (Group I) and conventional laparoscopy (Group II). For microlaparoscopic tubal sterilization a micro-telescope of 1.7 mm was used. Postoperative pain level was evaluated with the use of the visual analog scale (VAS) with scores ranging from 1 to 10. The groups were comparable in age, body mass index (BMI), and educational status. Group I had significantly lower VAS pain scores at 30-min (p=0.024), 1-h (p=0.038), and 2-h (p=0.016) intervals, although the 24-h (p=0.655) and 48-h (p=0.988) scores of the two groups were similar. While none of the patients in Group I needed additional postoperative analgesic drugs, 12% of the patients in Group II required additional analgesia. There were no operative complications in either of the groups, and none of the patients required conversion from the microlaparoscopic technique to a traditional method. In conclusion, our data suggest that for women needing surgical sterilization, microlaparoscopy has the advantage of a lower postoperative discomfort rate with regard to VAS pain scores, especially within the first 2 h.     

A randomized,placebo-controlled,dose-ranging trial comparing fulvestrant with goserelin in premenopausal patients with uterine fibroids awaiting hysterectomy

OBJECTIVE: To compare the use of a new antiestrogen fulvestrant with goserelin in reducing uterine fibroid growth before hysterectomy. DESIGN: An international, multicenter, randomized, placebo-controlled study. SETTING: Departments of obstetrics and gynecology. PATIENT(S): Premenopausal women (n = 307) diagnosed with uterine fibroids requiring hysterectomy. INTERVENTION(S): Over a 12-week period, patients received fulvestrant (50 mg, 125 mg, or 250 mg) as an i.m. injection, goserelin (3.6 mg) as a s.c. injection, or an injection-matched placebo once every 4 weeks. Patients underwent a hysterectomy at week 13. MAIN OUTCOME MEASURES: Efficacy endpoints included changes in fibroid growth, endometrial thickness, and uterine volume. The excretion of urinary markers of bone resorption was also examined. RESULT(S): Goserelin significantly reduced fibroid growth and endometrial thickness compared with placebos. Fulvestrant did not significantly alter fibroid volume or endometrial thickness or change endpoints such as endometrial histology or vaginal bleeding. Fulvestrant was associated with fewer postmenopause-related adverse events than goserelin. Goserelin, but not fulvestrant, significantly increased markers of bone resorption. CONCLUSION(S): At doses equivalent to those used for the treatment of breast cancer in postmenopausal women, fulvestrant did not significantly inhibit fibroid growth and, of particular note, did not lead to bone resorption.     

绝经后子宫出血患者子宫内膜的阴道超声形态学评分及其临床价值

目的：根据绝经后子宫出血患者子宫内膜的阴道超声检查形态设计评分方法，以利于临床筛选诊断性刮宫（诊刮）病例。方法：对１８２例绝经后子宫出血患者行阴道超声检查并进行评分，其中１３５例施行诊刮术，将每例的超声评分与诊刮的组织病理检查（病检）结果相比较。结果：患者评分高低与内膜的病检结果明显相关。评分＜３的７２例中仅１例（１．４％）为子宫内膜癌，而评分≥３的６３例中３２例（５０．８％）为子宫内膜癌。评分越高，内膜癌的真阳性率越高。结论：阴道超声检查可作为绝经后子宫出血患者筛选诊刮的手段，根据子宫内膜形态评分高低决定是否行诊刮有临床参考价值，但需进一步结合行腹部超声或（及）宫腔超声检查验证，即便是良性子宫内膜，亦需结合患者的临床具体情况决定是否行诊刮术。     

Comparison of Nonsteroidal Anti-Inflammatory Drugs and Misoprostol for Pain Relief during and after Hysterosalpingography: Prospective,Randomized, Controlled Trial

Study ObjectiveTo assess whether vaginal misoprostol or oral nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain during and 30 minutes after hysterosalpingography (HSG).DesignRandomized prospective, controlled, parallel-group study (Canadian Task Force classification I).SettingUniversity teaching hospital.PatientsOne hundred sixty-eight women with primary infertility who underwent HSG for evaluation of infertility.InterventionsPatients were randomly assigned to 1 of 3 groups. Group 1 received 200 μg misoprostol vaginally 6 hours before HSG; group 2, 50 mg diclofenac potassium orally 45 to 60 minutes before HSG; and group 3, no medication. The primary outcome of the study was to evaluate the severity of pain during and 30 minutes after the procedure using a visual analog scale (VAS) ranging from 1 (very favorable) to 10 (very unfavorable). The secondary outcomes were to assess the rate of completion and the vasovagal effects including nausea, vomiting, sweating, weakness, syncope, hypotension, and bradycardia.Measurements and Main ResultsThere was no statistically significant difference in the median (25%–75%) VAS pain scores between women administered vaginal misoprostol (median, 6.7 cm; range, 4.7–9 cm) and the control group (median, 6.7 cm; range, 4.6–8.8 cm) during the HSG. However, women in the NSAID group (median, 5.5 cm; range, 3–7.6 cm) reported less pain than did those in the misoprostol group (p = .009) and the control group (p = .03). At 30 minutes after HSG, there was no significant difference in the median VAS pain scores between patients administered NSAIDs (median, 2.3 cm; range, 1.4–4.2) or misoprostol (median, 2.3 cm; range, 1.2–4.4) and the control group (median, 2.2 cm; range, 1.3–4.4).ConclusionsThere is no benefit in terms of pain reduction with the use of misoprostol during HSG or at 30 minutes after the procedure. However, NSAIDs are associated with pain relief during the HSG procedure.     

Adjunctive erythromycin treatment for idiopathic preterm labor: results of a randomized, double-blinded, placebo-controlled trial

Pathogenesis and optimal treatment and prevention of preterm labor remain incompletely understood. Entry of cervical/vaginal microorganisms into lower uterine tissues has been implicated in preterm labor and may be amenable to specific therapy. Fifty-eight women with less than 34 completed weeks of gestation and without other obstetric complications, who were receiving intravenous tocolytics because of uterine contractions and who had cervical alteration (less than 5 cm dilated), were enrolled in a prospective randomized, double-blinded evaluation of 7 days of adjunctive therapy with enteric-coated erythromycin base (333 mg three times daily by mouth) versus placebo. Microbiologic examination included cultures for Neisseria gonorrhoeae, Chlamydia trachomatis, and group B streptococcus. Fifty-eight women with singleton pregnancies (29 erythromycin; 29 placebo) completed the protocol. Among women with cervical dilatation greater than or equal to 1 cm at the beginning of treatment, mean time until delivery was 32.5 days with erythromycin and 22.4 days with placebo treatment (p = 0.027). Of the erythromycin-treated women, seven of eight were delivered at greater than or equal to 37 weeks and only three of nine placebo-treated women were delivered at greater than or equal to 37 weeks (p = 0.035). Orally administered enteric-coated erythromycin as adjunctive treatment of pregnant women in labor less than or equal to 34 weeks is well tolerated. Adjunctive erythromycin given to women treated for preterm labor less than or equal to 34 weeks is associated with prolongation of pregnancy and delivery at 37 weeks only in women with cervical dilatation at the beginning of treatment.     

Comparison of the PainMatcher and the Visual Analogue Scale for assessment of labour pain following administered pain relief treatment

Objective

during childbirth, it is necessary to assess and monitor experienced pain and to evaluate the effect of pain relief treatment. The aim of this study was to compare the PainMatcher^® (PM) with the Visual Analogue Scale (VAS) for the assessment of labour pain and the effect of pain relief treatment.

Design

randomised controlled trial.

Setting

labour ward with approximately 2500 childbirths per year in western Sweden.

Participants

57 women with labour pain treated with acupuncture or sterile water injections scored their electrical pain threshold and pain intensity with the PM. Pain intensity was also assessed with the VAS. Electrical pain threshold and pain intensity were assessed immediately after a uterine contraction before and 30, 60, 90, 120, 150 and 180 minutes after treatment.

Measurements and findings

the results showed a weak correlation (r=0.13, p<0.05) between the pain intensity scores on the PM and the VAS. The PM detected changes (decrease) in pain intensity to a lower degree than the VAS. Surprisingly, in over 10% of sessions, women scored their pain intensity during a uterine contraction lower than their electrical pain threshold with the PM. However, electrical pain thresholds with the PM correlated well throughout all measurements.

Conclusions

the PM is a reliable tool for the assessment of electrical pain threshold; however, the VAS is more sensitive than the PM for recording changes in pain intensity when assessing the effects of treatment on labour pain.

Implications for practice

the PM and the VAS are not interchangeable in the case of labour pain, and there is still a need for research in this area to find a more suitable assessment instrument for the evaluation of labour pain.     

Effect of oral diclofenac potassium plus cervical lidocaine cream on pain perception during hysterosalpingography: A randomized,double-blind,placebo-controlled trial

Objective

The current study aims to investigate the analgesic effect of combining oral diclofenac potassium and cervical lidocaine cream for alleviating pain during HSG.

Clinical evaluation of early postpartum pain and healing outcomes after mediolateral versus lateral episiotomy

Objective

To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy (MLE) and lateral episiotomy (LE).

Methods

The prospective randomized study was conducted in the Czech Republic during 2010–2012. Consecutive primiparous women who gave birth at or after 37 weeks of pregnancy and had indications for an episiotomy were enrolled and randomly assigned to undergo MLE or LE. Patients were unaware of the episiotomy type performed. The primary outcomes were pain at 24 hours, 72 hours, and 10 days post partum, measured by a visual analog scale, verbal rating scale, interference with activities of daily living, and amount of analgesic use.

Results

The analysis included 266 women who underwent MLE and 297 women who underwent LE. Complete relief of pain was observed in 6 (2.3%) of 266 women after 24 hours, 21 (8.0%) of 264 after 72 hours, and 77 (29.1%) of 265 after 10 days in the MLE group, and in 11 (3.9%) of 285, 23 (7.7%) of 297, and 78 (26.4%) of 295 in the LE group, respectively (P = 0.36). There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used.

Conclusion

Incidence and extent of pain in the first 10 days after LE correspond to those after adequately performed MLE.     

A double-blind trial of hypogastric nerve block for postoperative pain relief following laparoscopic excision of endometriosis

Pre-sacral or sacral plexus nerve blocks are reported in the anaesthetic literature as effective in controlling pelvic pain, but are rarely performed as they are technically difficult. The pre-sacral space, however, is easily assessable at laparoscopy, and it seemed that infiltration of local anaesthetic solution into this space might offer good pain relief for women undergoing operative laparoscopic procedures for endometriosis when there is destruction of the parietal peritoneum and in whom postoperative pain control, particularly in a day case environment, can prove difficult. Following an initial favorable report of procedure, preliminary clinical studies suggested that the procedure was safe and effective with apparently lower analgesia requirements in the immediate postoperative period. In order to evaluate this more systematically, a double-blind trial was undertaken comparing pre-sacral nerve blocks using chirocaine (10 ml 0.5%) against placebo 10 ml 0.9% saline.There were no competing interests.     

Efficacy of mefenamic acid and hyoscine for pain relief during saline infusion sonohysterography in infertile women: a double blind randomized controlled trial

Objectives

To evaluate the efficacy and level of satisfaction from mefenamic acid and hyoscine when used for pain relief during saline infusion sonohysterography.

Study design

In this double blind randomized controlled trial, 141 nulliparous women were allocated to receive 500 mg of mefenamic acid, 10 mg of hyoscine or a placebo, which was packed in the same outer capsule. Saline infusion sonohysterography (SIS) was performed 30 min later by one operator. Pain and satisfaction scores were evaluated using a 10 cm visual analog scale. Baseline characteristics, pain and satisfaction scores were compared among the three groups. Pain scores were recorded before, after catheter insertion, during, immediately after, and 30 min after the procedure.

Results

No statistically significant differences were found in baseline characteristics, pain and satisfaction scores among the three groups. Maximum pain during SIS was 4.40 ± 3.34, 4.67 ± 3.14 and 4.85 ± 3.19 in the mefenamic acid, hyoscine and placebo groups respectively. There was a 31.1% prevalence of intrauterine abnormality and the most frequent finding was endometrial polyp.

Conclusion

There is no benefit in using mefenamic acid and hyoscine in the prevention of pain occurring from SIS.     

Reiki therapy for postoperative oral pain in pediatric patients: Pilot data from a double-blind,randomized clinical trial

PurposeTo examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients.MethodsThis was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis.ResultsThirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures.ImplicationsOur study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients.     

A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery

Objective

To compare extra-abdominal repair of the uterine incision at cesarean delivery with in situ repair.

Methods

The present study was a double-blind randomized controlled trial conducted at a university hospital in Egypt during 2012–2013, and included women with an indication for cesarean delivery. Extra-abdominal repair was used in group 1 (n = 500) and in situ repair in group 2 (n = 500). The primary outcome measure was the surgery duration.

Results

Surgery duration was significantly longer in group 1 than group 2 (49.9 ± 2.3 minutes vs 39.9 ± 1.8 minutes; P < 0.001). More patients in group 1 than in group 2 had postoperative moderate-to-severe pain (165 [33.0%] vs 115 [23.0%]; P = 0.001) and needed additional postoperative analgesia (100 [20.0%] vs 50 [10.0%]; P < 0.001). Moreover, mean time to bowel movement was longer in group 1 than in group 2 (17.0 ± 2.7 hours vs 14.0 ± 1.9 hours; P < 0.001).

Conclusion

In situ uterine closure is more advantageous than extra-abdominal repair in terms of surgery duration, postoperative pain and need for additional analgesia, and return of bowel movement.ClinicalTrials.gov:NCT01723605     

Magnetic resonance imaging performs better than endocervical curettage for preoperative prediction of cervical stromal invasion in endometrial carcinomas

Objective

Preoperative identification of cervical stromal invasion in endometrial carcinoma is important to select patients for primary radical hysterectomy. The objective of this prospective implementation study was to assess if introduction of magnetic resonance imaging (MRI) in addition to the standardly applied endocervical curettage (ECC), improved the preoperative prediction of cervical stromal invasion.

Methods

Over a six-year period, a total of 338 patients were surgically staged after preoperative assessment of the uterine cervix by ECC (years 1 through 3), and a combination of MRI and ECC (years 4 through 6). Suggested presence of cervical stromal invasion based on ECC (n = 321) and MRI (n = 146) were compared for diagnostic performance applying surgical FIGO stage 2009 as reference standard.

Results

For assessment of cervical stromal invasion sensitivity (specificity) [accuracy] values were 65% (79%) [77%] for ECC and 59% (91%) [84%] for MRI. Among patients diagnosed with both preoperative tests (n = 129), MRI yielded significantly higher specificity (p = 0.001) and accuracy (p = 0.005) than ECC. MRI independently predicted cervical stromal invasion with an odds ratio (OR) of 11.2 (p < 0.001) compared to OR of 2.7 (p = 0.07) for ECC.

Conclusions

The diagnostic performance of MRI compares favorably to that of ECC for preoperative assessment of cervical stromal invasion in endometrial carcinoma. Thus, the findings in this prospective implementation study support the value of preoperative MRI for assessment of cervical stromal invasion before radical hysterectomy.     

Prospective, non-randomized phase 2 clinical trial of carboplatin plus paclitaxel with sequential radical pelvic radiotherapy for uterine papillary serous carcinoma

Objective

Uterine Papillary Serous Carcinoma (UPSC) is uncommon and accounts for less than 5% of all uterine cancers. Therefore the majority of evidence about the benefits of adjuvant treatment comes from retrospective case series. We conducted a prospective multi-centre non-randomized phase 2 clinical trial using four cycles of adjuvant paclitaxel plus carboplatin chemotherapy followed by pelvic radiotherapy, in order to evaluate the tolerability and safety of this approach.

Methods

This trial enrolled patients with newly diagnosed, previously untreated patients with stage 1b-4 (FIGO-1988) UPSC with a papillary serous component of at least 30%. Paclitaxel (175 mg/m²) and carboplatin (AUC 6) were administered on day 1 of each 3-week cycle for 4 cycles. Chemotherapy was followed by external beam radiotherapy to the whole pelvis (50.4 Gy over 5.5 weeks). Completion and toxicity of treatment (Common Toxicity Criteria, CTC) and quality of life measures were the primary outcome indicators.

Results

Twenty-nine of 31 patients completed treatment as planned. Dose reduction was needed in 9 patients (29%), treatment delay in 7 (23%), and treatment cessation in 2 patients (6.5%). Hematologic toxicity, grade 3 or 4 occurred in 19% (6/31) of patients. Patients' self-reported quality of life remained stable throughout treatment. Thirteen of the 29 patients with stages 1-3 disease (44.8%) recurred (average follow-up 28.1 months, range 8-60 months).

Conclusion

This multimodal treatment is feasible, safe and tolerated reasonably well and would be suitable for use in multi-institutional prospective randomized clinical trials incorporating novel therapies in patients with UPSC.     

Effect of oral hyoscine-N-butyl bromide on pain perception during hysterosalpingography: A randomized,double-blind,placebo controlled trial

Objectives

The current study aims to investigate the analgesic effect of oral hyoscine-N-butyl bromide (HBB) for alleviating pain during hysterosalpingography (HSG).

Efficacy of Tribulus Terrestris for the treatment of premenopausal women with hypoactive sexual desire disorder: a randomized double-blinded,placebo-controlled trial

Although hypoactive sexual desire disorder (HSDD) is the most common sexual complaint, there is no consensus for the ideal treatment. Our study aimed to evaluate the efficacy of treating premenopausal women with HSDD with Tribulus terrestris and its effect on the serum levels of testosterone. We performed a prospective, randomized, double-blind, placebo-controlled trial, with 40 premenopausal women reporting diminished libido, receiving T. terrestris or placebo. The questionnaires FSFI and the QS-F were used to evaluate sexual dysfunction before and after treatment. Patients treated with T. terrestris experienced improvement in total score of FSFI (p?p?p?=?.005), “lubrication” (p?=?.001), “orgasm” (p?<.001), “pain” (p?=?.030) and “satisfaction” (p?=?.001). Treatment with placebo did not improve the scores for the “lubrication” and “pain”. QS-F scores showed that patients using T. terrestris had improvements in “desire” (p?=?.012), “sexual arousal/lubrication” (p?=?.002), “pain” (p?=?.031), “orgasm” (p?=?.004) and “satisfaction” (p?=?.001). Women treated with placebo did not score improvements. Women receiving T. terrestris had increased levels of free (p?=?.046) and bioavailable (p?T. terrestris might be a safe alternative for the treatment of premenopausal women with HSDD as it was effective in reducing the symptoms, probably due to an increase in the serum levels of free and bioavailable testosterone.