Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

— SALC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00492453
• Other study ID #: UThessaly 9-04
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2007
• Last updated: January 13, 2010
• Start date: September 2004
• Est. completion date: September 2010

Study information

• Verified date: June 2008
• Source: University of Thessaly
• Contact: George Tzovaras, MD
• Phone: +30 2410 682730
• Email: gtzovaras[@]hotmail.com
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia
• Pain, Postoperative
• Postoperative Pain
• Spinal Anesthesia

Intervention

Procedure:
• laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Laparoscopic cholecystectomy under spinal anesthesia: a pilot study. Surg Endosc. 2006 Apr;20(4):580-2. Epub 2006 Jan 25. — View Citation

Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Spinal vs general anesthesia for laparoscopic cholecystectomy: interim analysis of a controlled randomized trial. Arch Surg. 2008 May;143(5):497-501. doi: 10.1001/archsurg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		24hrs	No
Secondary	complications		30 days	Yes
Secondary	hospital stay		time from intervention to discharge	No
Secondary	patient satisfaction		within 2 weeks from intervention	No