Pain After Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Isoflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patient ages 18-64
- American Society of Anesthesiology Physical Status I, II or III
- Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Exclusion Criteria:
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Scheduled for ambulatory surgery
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Allergy to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
- Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
- Patient or surgeon refusal
Sites / Locations
- Ben Taub General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Desflurane
Sevoflurane
Isoflurane
Propofol
Arm Description
General Anesthesia with Desflurane
General Anesthesia with Sevoflurane
General Anesthesia with Isoflurane
General Anesthesia with Propofol
Outcomes
Primary Outcome Measures
Pain Measured on Verbal Scale of 0-10
Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Secondary Outcome Measures
Full Information
NCT ID
NCT00983918
First Posted
September 22, 2009
Last Updated
January 15, 2019
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00983918
Brief Title
Pain After Laparoscopic Cholecystectomy
Official Title
Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
General Anesthesia with Desflurane
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
General Anesthesia with Sevoflurane
Arm Title
Isoflurane
Arm Type
Active Comparator
Arm Description
General Anesthesia with Isoflurane
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
General Anesthesia with Propofol
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Description
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion
Primary Outcome Measure Information:
Title
Pain Measured on Verbal Scale of 0-10
Description
Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Exclusion Criteria:
Open cholecystectomy - excluded due to increased levels of pain in open procedures
Scheduled for ambulatory surgery
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
Allergy to any of the study medications or anesthetic agents
Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz, MD
Organizational Affiliation
Baylor College of Medicine, Dept. of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pain After Laparoscopic Cholecystectomy
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