Senagore 2003.
Methods | RCT Approved by the Institutional Review Board and informed consent obtained Setting: United States of America Funding: unspecified |
|
Participants | 38 patents scheduled for segmental laparoscopic colectomy | |
Interventions |
Treatment group: TEA (T8‐T9 or T9‐T10) with bupivacaine 0.1% and fentanyl 20 mcg/mL for 18 hours (n = 18) Control group: IV PCA with morphine for 18 hours (n = 20) General anaesthesia, diclofenac 50 mg orally every 8 hours beginning the evening before surgery and continued after operation, ketorolac 30 mg within 30 minutes of completion of surgery and antiemetic prophylaxis of dexamethasone 8 mg and ondansetron 4 mg for all participants |
|
Outcomes | VAS scores at movement at 6 and 24 hours Hospital length of stay (Criteria for discharge from hospital in both groups of participants included tolerance of 3 consecutive general meals without nausea or vomiting, adequate pain control with oral analgesics and passage of flatus. Length of hospital stay was defined as the number of nights spent in hospital from day of operation until discharge) |
|
Notes | Investigators reported no instances of TEA catheter malfunction or complications that required early removal of the catheter | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated random number after giving informed consent" |
Allocation concealment (selection bias) | Low risk | "computer‐generated random number after giving informed consent" |
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 | "There were no instances of thoracic epidural catheter malfunction or complications that required early removal of the catheter" "Forty‐seven patients were randomized during the study but four (two thoracic epidural and two IV opioids) had no resection or a second surgical procedure during their hospital stay, and five (three TEA and two PCA) had protocol violations and were excluded from subsequent analysis" |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat: "whose operation was converted to open surgery after randomization were excluded from analysis" |