Pain After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Isoflurane; Drug: Desflurane; Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT00983918
• Lead Sponsor: Baylor College of Medicine

Brief Summary

To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.

PURPOSE

To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2012-02-14
• Results First Submitted QC: 2014-01-25
• Results First Posted: 2014-03-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria

1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Scheduled for ambulatory surgery
3. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
4. Allergy to any of the study medications or anesthetic agents
5. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
6. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
7. Patient or surgeon refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoflurane	Isoflurane	General Anesthesia with Isoflurane
Desflurane	Desflurane	General Anesthesia with Desflurane
Sevoflurane	Sevoflurane	General Anesthesia with Sevoflurane
Propofol	Propofol	General Anesthesia with Propofol

Primary Outcome Measures

Name	Time	Method
Pain Measured on Verbal Scale of 0-10	24 hours	Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States