Blumenthal 2005.
Methods | Triple‐blinded (participant, provider, outcome assessor) randomized placebo‐controlled clinical trial Sequence generation via randomized list Follow‐up: 3 months |
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Participants | Participants: 36 adult participants at a university clinic in Zurich, Switzerland Operation: Bakart repair for shoulder instability using autogenous bone graft, harvested from iliac crest 2 groups, size: 18/18 Age (± SD), group 1, 2: 25 (± 5), 26 (± 4) Men/women, group 1, 2: 14/4, 13/5 Comorbidities: none reported Remarks: autogenous bone harvested through lateral oblique incision just cephalic to anterior iliac crest using classical surgical technique |
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Interventions |
Group 1 (ropivacaine): at end of surgery, bolus of 30 mL ropivacaine 0.5% via iliac crest catheter and in PACU, continuous infusion 0.2% ropivacaine at 5 mL/h started, continued for total of 48 h. Group 2 (placebo): at end of surgery, bolus of 30 mL saline via iliac crest catheter, in PACU, continuous infusion saline 5 mL/h started, continued for total of 48 h. Both groups: premedicated with midazolam 1 h before arrival to induction room, and interscalene brachial plexus block performed. GA with propofol, rocuronium and fentanyl. Autogenous bone harvested through lateral oblique incision cephalad to anterior iliac crest using classical surgical technique. Catheter placed in direct contact with self‐resorbing foam pad dressing touching bone, tunnelled and secured to skin using sutures and adhesive dressing. In PACU, all participants also received continuous interscalene analgesia with 0.2% ropivacaine at 10 mL/h 6 h after initial block. Both groups got IV PCA containing 1 mg/mL morphine, 2 mg dose lockout interval 15, no baseline, or 4 h limit, with 2 mg IV morphine top up by nurse for VAS > 30. After discharge, 25 mg oral rofecoxib/d and 2 mg oral paracetamol as needed during 3 weeks post‐op Adjuvants: none Immediate post‐op pain control: pain significantly lower at the iliac crest donor site at rest (except at t40 h) and during motion (except at t48 h) in the ropivacaine group with significantly decreased morphine consumption at 24 h and 48 h. |
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Outcomes | Dichotomous: none Continuous: VAS at rest and on motion at iliac crest at 3 months Other reported: post‐op pain at shoulder and presence of numbness/paraesthesias/neurologic damage at 3 months Adverse events: post‐op nausea/vomiting, pruritis, inflammation at catheter site |
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Notes | Interscalene block performed in both groups. Comparison of interest is ropivacaine vs placebo continuous infusion at iliac crest donor site. Funding sources: "support was provided solely from institutional and/or departmental sources." Conflicts of interest: no conflict of interest statement was provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were given a number between 1 and 36...according to a randomization list" |
Allocation concealment (selection bias) | Low risk | Quote: "patients were given a number between 1 and 36 by choosing a sealed envelope containing a number.. Each patient’s number was passed on to a pharmacist, who prepared the anaesthetic set (bolus and maintenance package) of either ropivacaine or placebo, according to a randomization list" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind study". Participants, block performers/anaesthesiologists, post‐op providers all blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all the patients were observed independently by a surgeon and an anaesthesiologist 3 months after surgery to assess the pain (anaesthesiologist) at rest and during motion at the operated IC and operated shoulder". Only pharmacy was aware of contents of anaesthetic set based on randomization list. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all patients completed the study. All interscalene catheters were successfully placed, and no disconnection or other technical problems were encountered during the course of the study" |
Selective reporting (reporting bias) | Low risk | Primary outcomes fully reported on |
Null bias | Low risk | Quote: "pain was significantly lower at the donor site at rest (except at t40hrs) and during motion (except at t48hrs) in the ropivacaine group" |