Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Spinal Anesthesia; General Anesthesia; Postoperative Pain
• Interventions: Procedure: laparoscopic cholecystectomy

• Registration Number: NCT00492453
• Lead Sponsor: University of Thessaly

Brief Summary

The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Status Verified: 2008-06
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14
• Primary Completion: 2010-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• elective laparoscopic cholecystectomy
• ASA I, II
• BMI< 30
• normal coagulation profile

Exclusion Criteria

• acute cholecystitis / cholangitis / pancreatitis
• previous open surgery in the upper abdomen
• contraindication for pneumoperitoneum
• contraindication for spinal anesthesia (ie spinal deformity)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	laparoscopic cholecystectomy	Laparoscopic cholecystectomy under spinal anesthesia
2	laparoscopic cholecystectomy	Laparoscopic cholecystectomy under general anesthesia

Primary Outcome Measures

Name	Time	Method
postoperative pain	24hrs

Secondary Outcome Measures

Name	Time	Method
complications	30 days
hospital stay	time from intervention to discharge
patient satisfaction	within 2 weeks from intervention

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece