Clinical trial NCT00492453: Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
Official title: A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Anesthesia
General Anesthesia
Postoperative Pain
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Larissa University Hospital
First posted: 2007-06-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: postoperative pain
timeFrame: 24hrs
Secondary outcomes:
measure: complications
timeFrame: 30 days
measure: hospital stay
timeFrame: time from intervention to discharge
measure: patient satisfaction
timeFrame: within 2 weeks from intervention
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: University of Thessaly, School of Medicine
name: Constantine Hatzitheofilou, MD
role: STUDY_CHAIR
affiliation: University of Thessaly, School of Medicine
name: George Tzovaras, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Frank Fafoulakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s00464-005-0405-1. Epub 2006 Jan 25.
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.143.5.497.