Tedore 2009.
Methods | Randomized controlled trial | |
Participants | N = 220; adult; 110 male, 110 female; ASA 1‐3; surgery at or distal to elbow; American study | |
Interventions |
Injectate in both blocks: mepivacaine 1.5% with 1:200,000 epinephrine and 0.1 mEq/ml of sodium bicarbonate, injected in a body weight‐adjusted volume of 40‐50 ml for weight <50kg and 50‐60 ml for weight >50kg Sedation for block: intravenous midazolam up to 5mg Intraoperative sedation: none |
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Outcomes |
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Notes | Primary aim of study was to assess neurological
complications of the two techniques; not anaesthetic
efficacy. There was no specified time between block completion and start of surgery, but it was probably within 15‐20 minutes. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “sealed envelope, computer‐generated random number method...” |
Allocation concealment (selection bias) | Low risk | Quote: “sealed envelope, computer‐generated random number method...” |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Patient, operator, and assessor during block and the peri‐operative period was unblinded. The assessor of outcomes (patient satisfaction and complications) at 2 and 10 days following the block was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The exclusions of patients were explained clearly in the Results. The review authors believe the risk of bias is low |
Selective reporting (reporting bias) | Low risk | All stated outcomes were reported |
Other bias | Unclear risk | A weight‐based formula was used to calculate local anaesthetic volume, but the volumes were high rather than low. The patients were prepped for surgery 10‐15 minutes after completion of the block, and surgery commenced shortly thereafter; this shortened interval to surgery may have reduced the incidence of surgical anaesthesia. |