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Pain After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Desflurane

Sevoflurane

Isoflurane

Propofol

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

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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