Preoperative Pain Control in Gastric Bypass Surgery Patients

NCT ID: NCT01801189

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-01-31

Brief Summary

Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Detailed Description

Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.

Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:

• Post-operative analgesic requirements
• Post-operative pain scale (rated 0-10)
• Episodes of vomiting
• Post-operative antiemetic requirement
• Length of stay

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin

Single, 300 mg pre-operative oral dose of Pregabalin.

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: DRUG

One 300 mg oral dose of Pregabalin given before surgery.

Sugar Pill

Single, placebo pre-operative dose.

Group Type: PLACEBO_COMPARATOR

Placebo (for Pregabalin)

Intervention Type: DRUG

One oral dose of placebo given before surgery.

Interventions

Pregabalin

One 300 mg oral dose of Pregabalin given before surgery.

Intervention Type: DRUG

Placebo (for Pregabalin)

One oral dose of placebo given before surgery.

Intervention Type: DRUG

Other Intervention Names

Lyrica; Sugar pill manufactured to mimic Pregabalin 300 mg tablet

Eligibility Criteria

Inclusion Criteria

• Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Legacy Health System

OTHER

Sponsor Role: lead

Responsible Party

Valerie Halpin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerie Halpin, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Health System

Locations

Legacy Good Samaritan Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

H001

Identifier Type: -

Identifier Source: org_study_id