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Trial record 59 of 424 for:    Pregabalin

Preoperative Pain Control in Gastric Bypass Surgery Patients

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ClinicalTrials.gov Identifier: NCT01801189
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Valerie Halpin, Legacy Health System

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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Pregabalin Drug: Placebo (for Pregabalin) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 300 mg Will Improve Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass (Bariatric Surgery)
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin
Single, 300 mg pre-operative oral dose of Pregabalin.
Drug: Pregabalin
One 300 mg oral dose of Pregabalin given before surgery.
Other Name: Lyrica

Placebo Comparator: Sugar Pill
Single, placebo pre-operative dose.
Drug: Placebo (for Pregabalin)
One oral dose of placebo given before surgery.
Other Name: Sugar pill manufactured to mimic Pregabalin 300 mg tablet




Primary Outcome Measures :
  1. Post-operative pain medication requirements [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]

Secondary Outcome Measures :
  1. Post-operative Pain Scale [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]

Other Outcome Measures:
  1. Episodes of vomiting [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801189


Locations
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United States, Oregon
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Valerie Halpin, MD Legacy Health System

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Responsible Party: Valerie Halpin, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT01801189     History of Changes
Other Study ID Numbers: H001
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pregabalin
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs