Skip to content

Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00492453
Acronym
SALC
Enrollment
300
Registered
2007-06-27
Start date
2004-09-30
Completion date
2010-09-30
Last updated
2010-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Postoperative Pain, Spinal Anesthesia

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.

Interventions

PROCEDURElaparoscopic cholecystectomy

elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

Sponsors

Larissa University Hospital
CollaboratorOTHER
University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
postoperative pain24hrs

Secondary

MeasureTime frame
complications30 days
hospital staytime from intervention to discharge
patient satisfactionwithin 2 weeks from intervention

Countries

Greece

Contacts

Primary ContactGeorge Tzovaras, MD
gtzovaras@hotmail.com+30 2410 682730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026