Barratt 2002.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Australia Funding: governmental |
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| Participants | 47 adult patients, aged 18 to 80 years, undergoing major open upper abdominal surgery for which the medical management plan called for a period of gut rest for the first 10 to 14 postoperative days. Surgical blocks included Whipple procedure, gastrojejunostomy, hepato‐biliary surgery,
gastrectomy and others. All required midline incisions from T7 to T11 dermatomes Excluded were patients with significant cardiac disease (severe angina, congestive cardiac failure, recent acute myocardial infarction); respiratory disease (preoperative PaO2 50 mm Hg (room air), PaCO2 50 mm Hg (room air)); renal disease (plasma creatinine 0.2 mmol/L); musculoskeletal or neurological disease; haematological disease; drug dependency disorder; or psychiatric disease |
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| Interventions |
Treatment groups: TEA T7‐T8, T8‐T9, or T9‐T10 interspace, and a block was established to T4 using bupivacaine 0.5%. Intraoperative block was maintained with bupivacaine 0.5% and was continued postoperatively for a minimum of 48 hours, with an infusion of bupivacaine 0.25% with fentanyl 2.5 mcg/mL at 5 to 10 mL/h. With (n = 12) or without (n =13) intravenous parenteral nutrition. At the conclusion of anaesthesia, 20 to 30 mg ketorolac tromethamine was administered intramuscularly,
and 10 to 15 mg was administered every 6 hours up to 48 hours Control group: intravenous PCA with fentanyl (n = 1) or morphine. With (n = 10) or without (n =12) intravenous parenteral nutrition General anaesthesia for all participants |
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| Outcomes | VAS scores at rest at 6, 24 and 48 hours VAS scores on movement at 6, 24 and 48 hours Anastomotic leak Length of hospital stay |
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| Notes | Study authors contacted on 6 April 2015, but did not reply | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly allocated cards in sealed envelopes" |
| Allocation concealment (selection bias) | Low risk | "randomly allocated cards in sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up mentioned |
| Selective reporting (reporting bias) | Low risk | All results provided |
| Other bias | Unclear risk | Ketorolac for 48 hours in the epidural group only |