Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy (SALC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492453
Recruitment Status : Unknown
Verified June 2008 by University of Thessaly.
Recruitment status was:  Recruiting
First Posted : June 27, 2007
Last Update Posted : January 14, 2010
Larissa University Hospital
Information provided by:
University of Thessaly

June 26, 2007
June 27, 2007
January 14, 2010
September 2004
September 2010   (Final data collection date for primary outcome measure)
postoperative pain [ Time Frame: 24hrs ]
Same as current
Complete list of historical versions of study NCT00492453 on Archive Site
  • complications [ Time Frame: 30 days ]
  • hospital stay [ Time Frame: time from intervention to discharge ]
  • patient satisfaction [ Time Frame: within 2 weeks from intervention ]
  • morbidity [ Time Frame: 30 days ]
  • hospital stay
  • recovery [ Time Frame: 10-15 days ]
  • patient satisfaction [ Time Frame: 10-15 days ]
Not Provided
Not Provided
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Anesthesia
  • General Anesthesia
  • Postoperative Pain
Procedure: laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
  • Active Comparator: 1
    Laparoscopic cholecystectomy under spinal anesthesia
    Intervention: Procedure: laparoscopic cholecystectomy
  • Active Comparator: 2
    Laparoscopic cholecystectomy under general anesthesia
    Intervention: Procedure: laparoscopic cholecystectomy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
UThessaly 9-04
Not Provided
Not Provided
George Tzovaras, MD, University of Thessaly, School of Medicine
University of Thessaly
Larissa University Hospital
Study Chair: Constantine Hatzitheofilou, MD University of Thessaly, School of Medicine
Study Director: George Tzovaras, MD University of Thessaly, School of Medicine
Principal Investigator: Frank Fafoulakis, MD University Hospital of Larissa
University of Thessaly
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP