A cross-sectional study of the reporting quality of pilot or feasibility trials in high-impact anesthesia journals

Purpose

Pilot trials inform the design and conduct of larger scale trials. Using the Consolidated Standards of Reporting Trials (CONSORT) pilot extension guidelines, we assessed reporting quality in five high-impact anesthesia journals and explored factors associated with reporting quality.

Methods

The five highest-impact anesthesia journals were screened for randomized-controlled trials published as pilot or feasibility trials between 2006 and 2016. A pair of reviewers independently screened citations, extracted data, and assessed reporting quality using the CONSORT pilot trial extension checklists for abstracts and full texts. We reported the percentage adherence for each item, along with the median [interquartile range (IQR)] or mean (standard deviation [SD]) for all items. The factors considered to influence reporting were: 1) trial registration, 2) industry funding, 3) trial identification as a pilot or feasibility in the title or abstract, 4) primary objective as “feasibility”, and 5) the specific journal. The association was estimated using generalized estimating equations and reported as incidence rate ratios with 99% confidence intervals.

Results

Of 364 citations, 58 articles were eligible. The median [IQR] number of CONSORT abstract items reported was 5 [4-7], and the mean (SD) number of full text items reported was 13 (5). Significantly poor reporting was associated with “not registering the trial” (both abstracts and full texts), “trial not identified as a pilot” (abstracts), and “using clinical hypothesis as the primary objective” (full texts).

Conclusion

The reporting quality of pilot trials published in leading anesthesia journals is poor. Journal editorial boards can encourage improved reporting by supporting adherence to the CONSORT extension for pilot trials.

     

Opioid versus non-opioid analgesia for spine surgery: a systematic review and meta-analysis of randomized controlled trials

Purpose

Opioids are the primary analgesics used in patients undergoing spine surgery. Postoperative pain is common despite their liberal use and so are opioid-associated side effects. Non-opioid analgesics are gaining popularity as alternative to opioids in spine surgery.

Methods

This systematic review evaluated current evidence regarding opioid and non-opioid intraoperative analgesia and their influence on immediate postoperative pain and adverse events in spine surgery.

Results

A total of 10,459 records were obtained by searching Medline, EMBASE and Web of Science databases and six randomized controlled trials were included. Differences in postoperative pain scores between opioid and non-opioid groups were not significant at 1 h: 4 studies, mean difference (MD) = 0.65 units, 95% confidence intervals (CI) [−0.12 to 1.41], p = 0.10, but favored non-opioid at 24 h after surgery: 3 studies, MD = 0.75 units, 95%CI [0.03 to 1.46], p = 0.04. The time for first postoperative analgesic requirement was shorter (MD = −45.06 min, 95%CI [−72.50 to −17.62], p = 0.001), and morphine consumption during first 24 h after surgery was higher in opioid compared to non-opioid group (MD = 4.54 mg, 95%CI [3.26 to 5.82], p < 0.00001). Adverse effects of postoperative nausea and vomiting (Relative risk (RR) = 2.15, 95%CI [1.37 to 3.38], p = 0.0009) and shivering (RR = 2.52, 95%CI [1.08 to 5.89], p = 0.03) were higher and bradycardia was lower (RR = 0.35, 95%CI [0.17 to 0.71], p = 0.004) with opioid analgesia.

Conclusion

The certainty of evidence on GRADE assessment is low for studied outcomes. Available evidence supports intraoperative non-opioid analgesia for overall postoperative pain outcomes in spine surgery. More research is needed to find the best drug combination and dosing regimen.

Prospero Registration: CRD42020209042.

     

Acute epidural haematoma following epidural steroid injection in a patient with spinal stenosis

Extradural haematoma is a rare but known complication of neuraxial procedures. Although the literature quotes an incidence of 1:150,000 and 1:220,000 after epidural and spinal procedures, respectively, there is only a limited number of case reports described in pain practice. This case report describes an unusual occurrence of thoracic extradural haematoma following a lumbar epidural steroid injection. An entirely unique feature was its occurrence at a level distant to the site of injection, which has not been reported previously unless associated with catheterisation. We would like to highlight this report as it raises several pertinent and challenging questions; both for regional anaesthesia and pain practice.     

Erector spinae plane block vs. peri-articular injection for pain control after arthroscopic shoulder surgery: a randomised controlled trial

Interscalene brachial plexus block is the standard regional analgesic technique for shoulder surgery. Given its adverse effects, alternative techniques have been explored. Reports suggest that the erector spinae plane block may potentially provide effective analgesia following shoulder surgery. However, its analgesic efficacy for shoulder surgery compared with placebo or local anaesthetic infiltration has never been established. We conducted a randomised controlled trial to compare the analgesic efficacy of pre-operative T2 erector spinae plane block with peri-articular infiltration at the end of surgery. Sixty-two patients undergoing arthroscopic shoulder repair were randomly assigned to receive active erector spinae plane block with saline peri-articular injection (n = 31) or active peri-articular injection with saline erector spinae plane block (n = 31) in a blinded double-dummy design. Primary outcome was resting pain score in recovery. Secondary outcomes included pain scores with movement; opioid use; patient satisfaction; adverse effects in hospital; and outcomes at 24 h and 1 month. There was no difference in pain scores in recovery, with a median difference (95%CI) of 0.6 (−1.9–3.1), p = 0.65. Median postoperative oral morphine equivalent utilisation was significantly higher in the erector spinae plane group (21 mg vs. 12 mg; p = 0.028). Itching was observed in 10% of patients who received erector spinae plane block and there was no difference in the incidence of significant nausea and vomiting. Patient satisfaction scores, and pain scores and opioid use at 24 h were similar. At 1 month, six (peri-articular injection) and eight (erector spinae plane block) patients reported persistent pain. Erector spinae plane block was not superior to peri-articular injection for arthroscopic shoulder surgery.