Pain After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983918
• Other study ID #: H-24815
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Desflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
• Sevoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
• Isoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
• Propofol
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours