Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy (SALC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Thessaly.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Larissa University Hospital
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00492453
First received: June 26, 2007
Last updated: January 13, 2010
Last verified: June 2008

June 26, 2007
January 13, 2010
September 2004
September 2010   (final data collection date for primary outcome measure)
postoperative pain [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
postoperative pain [ Time Frame: 24hrs ]
Complete list of historical versions of study NCT00492453 on ClinicalTrials.gov Archive Site
  • complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • hospital stay [ Time Frame: time from intervention to discharge ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: within 2 weeks from intervention ] [ Designated as safety issue: No ]
  • 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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)
Both
18 Years to 65 Years
Yes
Contact: George Tzovaras, MD +30 2410 682730 gtzovaras@hotmail.com
Greece
 
NCT00492453
UThessaly 9-04
Yes
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