Rosenfeld 2016.
Methods | Parallel group RCT. | |
Participants | In USA, 130 participants ASA I‐III participants undergoing shoulder surgery (arthroplasty, open and arthroscopic rotator cuff repair and acromisoplasty) with ultrasound‐guided brachial plexus block were included. Participants taking more than 60 mg oral morphine equivalents per day, those with diabetes mellitus, allergy to local anaesthetic or dexamethasone, coagulopathy, local infection or severe lung disease were excluded. | |
Interventions |
Block All participants received brachial plexus block with ropivacaine 0.5% 28 ml. Dexamethasone/placebo Dexamethasone group: dexamethasone 8 mg perineurally and normal saline 5 ml intravenously. Intravenous dexamethasone group: dexamethasone, 8 mg intravenously and normal saline 5 ml mixed with the block solution. Placebo group: normal saline 5 ml both intravenously and mixed with the block solution. Intraoperative anaesthesia/analgesia All participants received fentanyl IV up to 100 micrograms and midazolam up to 4 mg for sedation for block placement. All participants underwent general anaesthesia with propofol, fentanyl, rocuronium and/or succinylcholine, sevoflurane in air‐oxygen and ondansetron. Intraoperative fentanyl was limited to 250 micrograms and no long‐acting opioids were used. Neuromusclular block was reversed with neostigmine/glycopyrrolate. Postoperative analgesia For participants not discharged the day of surgery, ketorolac IV was given every six hours for the first 24 hours and intravenous morphine or hydromorphone and oral hydrocodone or oxycodone as needed. Participants who were discharged the day of surgery were prescribed ibuprofen 800 mg every eight hours and hydrocodone, oxycodone and non‐steroidal anti‐inflammatory medications as needed. |
|
Outcomes |
Outcomes of interest for the review Duration of sensory block defined as the time until the patient detected complete resolution of sensory block in the shoulder region. 24‐hour postoperative opioid consumption. Pain scores at rest measured on 11‐point VAS 12 , 24 and 48 hours after surgery. Satisfaction with pain placebo. Incidence of adverse events. Other outcomes Pain scores at rest measured on 11‐point VAS 8 hours, 20 hours, and 1 week after surgery. |
|
Notes | Funding: none. Conflicts of interest: none. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence was generated by a statistician. |
Allocation concealment (selection bias) | Low risk | Treatment allocation schedule was stored by the pharmacy and randomization occurred after informed consent was obtained and before any study drugs were prepared. |
Blinding of participants (detection bias) | Low risk | The clinicaltrials.gov protocol states that participants were blinded. |
Blinding of personnel (detection bias) | Low risk | The clinicaltrials.gov document states personnel was blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The clinicaltrial.gov document states outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only two participants were excluded form the perineural dexamethasone group, five from the intravenous group and three from the placebo group. |
Selective reporting (reporting bias) | Low risk | Protocol was registered on clinicaltrial.gov. All outcomes were reported as stated in the protocol. |
Other bias | Low risk | Appears to be free of any other bias. |