Elkaradawy 2011.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Egypt Funding: unspecified |
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Participants | 50 ASA 2 type 2 diabetic patients undergoing open cholecystectomy with negative stress exercise test and at least 2 cardiac risk factors preoperatively Exclusion criteria were history of coronary heart disease; hypertension; respiratory, renal or hepatic insufficiency; or contraindication to epidural analgesia |
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Interventions |
Treatment group: thoracic (T7‐T8 and advanced 3 cm) epidural analgesia with 15 mL of 0.2% ropivacaine and fentanyl 2 mcg/mL followed by 5 to 8 mL/h of 0.1% ropivacaine plus fentanyl 1 mcg/mL at 5 to 8 mL/h for 24 hours (n = 25) Control group: IV patient‐controlled analgesia with morphine (n = 25) General anaesthesia for all participants |
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Outcomes | Pain: less pain with epidural analgesia | |
Notes | Results not extractable. Study authors contacted on 15 June 2014, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "block‐wise balanced randomization" |
Allocation concealment (selection bias) | Low risk | "on cards sealed into opaque envelopes", "opened after taking decision to operate" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "neutral observer blinded with anaesthetic and analgesic techniques" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced |