Clinical trial NCT02317510: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy
Official title: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Stone Disease
Polyp
Keywords: Combined anesthesia
General anesthesia
Laparoscopic cholecystectomy
Lead sponsor: Lütfiye Nuri Burat Government Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Haseki Training and Research Hospital
First posted: 2014-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Detailed description: Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.

Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.

Eligibility criteria: Inclusion Criteria:

* Gall stone disease, polyp

Exclusion Criteria:

* Gall bladder cancer

Primary outcomes:
measure: Duration of Operation
timeFrame: up to 2 hours
measure: Post-operative Shoulder Pain
timeFrame: from end of the operation to postoperative 3 days
Secondary outcomes:
measure: Duration of Anaesthesia
timeFrame: up to 2 hours
measure: Post-operative Abdominal Pain 2nd Hour
timeFrame: pain at postoperative 2nd hour
measure: Post-operative Abdominal Pain 4th Hour
timeFrame: pain at postoperative 4th hour
measure: Post-operative Abdominal Pain 6th Hour
timeFrame: pain at postoperative 6th hour
measure: Post-operative Abdominal Pain 12th Hour
timeFrame: pain at postoperative 12th hour
measure: Post-operative Abdominal Pain 24th Hour
timeFrame: pain at postoperative 24th hour
measure: Intra-operative Shoulder Pain
timeFrame: during operation time, up to 2 hours
measure: Urinary Retention
timeFrame: from end of the operation to postoperative 1 day
measure: Nausea/Vomiting
timeFrame: from end of the operation to postoperative 1 day
measure: Headache
timeFrame: from end of the operation to postoperative 3 days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Lutfiye NBGH
Study officials:
affiliation: Lutfiye NBGH
name: Turgut Donmez, operator MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11.