Pain After Laparoscopic Cholecystectomy

January 15, 2019 updated by: Jaime Ortiz, Baylor College of Medicine

Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desflurane
General Anesthesia with Desflurane
Drug: Desflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
Active Comparator: Sevoflurane
General Anesthesia with Sevoflurane
Drug: Sevoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
Active Comparator: Isoflurane
General Anesthesia with Isoflurane
Drug: Isoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
Active Comparator: Propofol
General Anesthesia with Propofol
Drug: Propofol
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Measured on Verbal Scale of 0-10
Time Frame: 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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Jaime Ortiz, MD, Baylor College of Medicine, Dept. of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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