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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
  Purpose

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.


Condition Intervention
Spinal Anesthesia
General Anesthesia
Postoperative Pain
Procedure: laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients

Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Laparoscopic cholecystectomy under spinal anesthesia
Procedure: laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
Active Comparator: 2
Laparoscopic cholecystectomy under general anesthesia
Procedure: laparoscopic cholecystectomy
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492453

Contacts
Contact: George Tzovaras, MD +30 2410 682730 gtzovaras@hotmail.com

Locations
Greece
University Hospital of Larissa Recruiting
Larissa, Thessaly, Greece, 411 10
Contact: George Tzovaras, MD    +30 2410 682730    gtzovaras@hotmail.com   
Principal Investigator: Frank Fafoulakis, MD         
Sub-Investigator: George Vretzakis, MD         
Sub-Investigator: Georgia Stamatiou, MD         
Sub-Investigator: Konstantinos Pratsas, MD         
Sub-Investigator: Stavroula Georgopoulou, MD         
Sub-Investigator: Efi Petinaki, MD         
Sponsors and Collaborators
University of Thessaly
Larissa University Hospital
Investigators
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
  More Information

Publications:
Responsible Party: George Tzovaras, MD, University of Thessaly, School of Medicine
ClinicalTrials.gov Identifier: NCT00492453     History of Changes
Other Study ID Numbers: UThessaly 9-04
Study First Received: June 26, 2007
Last Updated: January 13, 2010
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014