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Interim Analysis of a Controlled Randomized Trial

George Tzovaras, MD; Frank Fafoulakis, MD; Kostantinos Pratsas, MD; Stavroula Georgopoulou, MD; Georgia Stamatiou, MD; Constantine Hatzitheofilou, MD

Arch Surg. 2008;143(5):497-501.

Objective  To compare spinal anesthesia with the gold standard general anesthesia for elective laparoscopic cholecystectomy in healthy patients.

Design  Controlled randomized trial.

Setting  University hospital.

Patients  One hundred patients with symptomatic gallstone disease and American Society of Anesthesiologists status I or II were randomized to have laparoscopic cholecystectomy under spinal (n = 50) or general (n = 50) anesthesia.

Methods  Intraoperative parameters, postoperative pain, complications, recovery, and patient satisfaction at follow-up were compared between the 2 groups.

Results  All the procedures were completed by the allocated method of anesthesia, as there were no conversions from spinal to general anesthesia. Pain was significantly less at 4 hours (P < .001), 8 hours (P < .001), 12 hours (P < .001), and 24 hours (P = .02) after the procedure for the spinal anesthesia group compared with those who received general anesthesia. There was no difference between the 2 groups regarding complications, hospital stay, recovery, or degree of satisfaction at follow-up.

Conclusions  Spinal anesthesia is adequate and safe for laparoscopic cholecystectomy in otherwise healthy patients and offers better postoperative pain control than general anesthesia without limiting recovery.

Trial Registration  clinicaltrials.gov Identifier: NCT00492453

Author Affiliations: Departments of Surgery (Drs Tzovaras, Fafoulakis, and Hatzitheofilou) and Anesthesiology (Drs Pratsas, Georgopoulou, and Stamatiou), University of Thessaly Medical School, University Hospital of Larissa, Larissa, Greece.

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