Anaesthetists’ risk assessment of placebo nerve block studies using the SHAM (Serious Harm and Morbidity) scale

Jarman, Jay; Marks, Nila; Fahy, Cormac; Costi, David; Cyna, Allan M

doi:10.1111/j.1365-2044.2011.06998.x

Cited by 16 publications

(10 citation statements)

References 21 publications

(47 reference statements)

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“…Abdallah et al randomization method, allocation concealment, use of noninvasive sham blocks, 55,56 and the blinding of patients, anesthesiologists providing clinical care, and assessors. Our assessment of the success of patient blinding indicated that it was successfully maintained.…”

Section: Subomohyoid-suprascapular Versus Interscalene Blockmentioning

confidence: 99%

Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery

et al. 2020

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Background: Interscalene brachial plexus block, the pain relief standard for shoulder surgery, is an invasive technique associated with important complications. The subomohyoid anterior suprascapular block is a potential alternative, but evidence of its comparative analgesic effect is sparse. The authors tested the hypothesis that anterior suprascapular block is noninferior to interscalene block for improving pain control after shoulder surgery. As a secondary objective, the authors evaluated the success of superior trunk (C5-C6 dermatomes) block with suprascapular block. Methods:In this multicenter double-blind noninferiority randomized trial, 140 patients undergoing shoulder surgery were randomized to either interscalene or anterior suprascapular block with 15 ml of ropivacaine 0.5% and epinephrine. The primary outcome was area under the curve of postoperative visual analog scale pain scores during the first 24 h postoperatively. The 90% CI for the difference (interscalene-suprascapular) was compared against a -4.4-U noninferiority margin. Secondary outcomes included presence of superior trunk blockade, pain scores at individual time points, opioid consumption, time to first analgesic request, opioid-related side-effects, and quality of recovery.Results: A total of 136 patients were included in the analysis. The mean difference (90% CI) in area under the curve of pain scores for the (interscalene-suprascapular) comparison was -0.3 U (-0.8 to 0.12), exceeding the noninferiority margin of -4.4 U and demonstrating noninferiority of suprascapular block. The risk ratio (95% CI) of combined superior trunk (C5-C6 dermatomes) blockade was 0.98 (0.92 to 1.01), excluding any meaningful difference in superior trunk block success rates between the two groups. When differences in other analgesic outcomes existed, they were not clinically important.conclusions: The suprascapular block was noninferior to interscalene block with respect to improvement of postoperative pain control, and also for blockade of the superior trunk. These findings suggest that the suprascapular block consistently blocks the superior trunk and qualify it as an effective interscalene block alternative. What We Already Know about This Topic• Interscalene brachial plexus block is a commonly used procedure for shoulder surgery, but it can be associated with important complications What This Article Tells Us That Is New• Subomohyoid anterior suprascapular block is noninferior to interscalene block in providing analgesia for the first 24 h after shoulder surgery • Subomohyoid anterior suprascapular block does not appear to differ significantly from interscalene block in terms of superior trunk blockade or overall quality of recovery T he ongoing quest for effective alternatives to the interscalene block of the brachial plexus for postoperative analgesia after shoulder surgery 1 has been prompted by the interscalene block's invasiveness 2,3 and undesirable respiratory side effects related to phrenic nerve block, 4 which restrict its use in certain population...

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Section: Subomohyoid-suprascapular Versus Interscalene Blockmentioning

confidence: 99%

Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery

et al. 2020

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“…Some of the included studies may raise ethical concerns since they worked with invasive placebo (so-called shamcontrol). The SHAM (serious harm and morbidity) scale classifies the risk of saline injection as placebo control of TAP block as highest (grade 4) [55].…”

Section: Very Low Certaintymentioning

confidence: 99%

Transversus Abdominis Plane Block Appears to Be Effective and Safe as a Part of Multimodal Analgesia in Bariatric Surgery: a Meta-analysis and Systematic Review of Randomized Controlled Trials

et al. 2020

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Purpose Pain after bariatric surgery can prolong recovery. This patient group is highly susceptible to opioid-related side effects. Enhanced Recovery After Surgery guidelines strongly recommend the administration of multimodal medications to reduce narcotic consumption. However, the role of ultrasound-guided transversus abdominis plane (USG-TAP) block in multimodal analgesia of weight loss surgeries remains controversial. Materials and Methods A systematic search was performed in four databases for studies published up to September 2019. We considered randomized controlled trials that assessed the efficacy of perioperative USG-TAP block as a part of multimodal analgesia in patients with laparoscopic bariatric surgery. Results Eight studies (525 patients) were included in the meta-analysis. Pooled analysis showed lower pain scores with USG-TAP block at every evaluated time point and lower opioid requirement in the USG-TAP block group (weighted mean difference (WMD) = − 7.59 mg; 95% CI − 9.86, − 5.39; p < 0.001). Time to ambulate was shorter with USG-TAP block (WMD = − 2.22 h; 95% CI − 3.89, − 0.56; p = 0.009). This intervention also seemed to be safe: only three non-severe complications with USG-TAP block were reported in the included studies. Conclusion Our results may support the incorporation of USG-TAP block into multimodal analgesia regimens of ERAS protocols for bariatric surgery.

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“…The Serious Harm and Morbidity (SHAM) score is used to grade the severity of potential complications of placebocontrolled interventions in local anaesthesia research and it is, perhaps, of note that pneumothorax is listed as a potential complication with a grade 4 SHAM score, which represents a major risk. 3 In order to perform TPVB while minimizing the risk of pneumothorax, the clinician must have the relevant anatomical knowledge. The present study aimed to identify the depth of needle insertion required to reach the paravertebral space, and the distance from the spinous process to the insertion point on the skin, using chest computed tomography (CT) scanning of paediatric patients.…”

Section: Introductionmentioning

confidence: 99%

Anatomical Investigations for Appropriate Needle Positioning for Thoracic Paravertebral Blockade inChildren

et al. 2012

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Anaesthetists’ risk assessment of placebo nerve block studies using the SHAM (Serious Harm and Morbidity) scale

Cited by 16 publications

References 21 publications

Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery

Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery

Transversus Abdominis Plane Block Appears to Be Effective and Safe as a Part of Multimodal Analgesia in Bariatric Surgery: a Meta-analysis and Systematic Review of Randomized Controlled Trials

Anatomical Investigations for Appropriate Needle Positioning for Thoracic Paravertebral Blockade inChildren

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