Tyagi 2011.
Methods | RCT Approved by Institutional Revie\v Board and informed written consent obtained from all patients Setting: India Funding: departmental resources only |
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Participants | 66 patients of ASA physical status 2 to 3, aged 18 to 65 years, scheduled for emergency laparotomy in view of peritonitis due to perforation in the small intestine | |
Interventions |
Treatment group: TEA (T8‐T9 or T9‐T10 and catheter advanced 3 cm passed the needle tip) with bupivacaine 0.125% plus fentanyl during surgery and bupivacaine 0.125% thereafter for 48 hours (n = 33) Control group: IV tramadol (n = 33) General anaesthesia for all participants |
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Outcomes | Time to first flatus Time to first faeces Leak Hospital LOS |
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Notes | "None of the patients in group GT developed epidural abscess or meningitis post‐operatively" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Sealed opaque envelopes" |
Allocation concealment (selection bias) | Low risk | "Sealed opaque 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 |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Unclear risk | For the 2 participants with failed epidural blockade, missing data were replaced by the "worst possible recorded outcome in group GT" The 2 groups were similar with regard to demographic profiles and baseline haemodynamic parameters, signs of SIRS, ASA status 2 and 3 , modified APACHE score and MPI score 2 failed‐block analysed in intention‐to‐treat |