Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients

Conditions
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Spinal Anesthesia, General Anesthesia, Postoperative Pain

Intervention / Treatment
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* Procedure: laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Laparoscopic cholecystectomy under spinal anesthesia | Procedure: laparoscopic cholecystectomy<br>* elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia<br>|
| Active Comparator: 2<br>Laparoscopic cholecystectomy under general anesthesia | Procedure: laparoscopic cholecystectomy<br>* elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | 30 days | 
| hospital stay |  | time from intervention to discharge | 
| patient satisfaction |  | within 2 weeks from intervention |