Preoperative Pain Control in Gastric Bypass Surgery Patients

Legacy Health System

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain

Treatments: Drug: Placebo (for Pregabalin); Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT01801189

H001

Details and patient eligibility

About

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.

Full 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

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin

Sugar Pill

Placebo Comparator group

Description:

Single, placebo pre-operative dose.

Treatment:

Drug: Placebo (for Pregabalin)