Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00886236
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its ability to reduce postoperative pain, the need for morphine-like pain medication, and the severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass surgery patients.


Condition Intervention
Obesity, Morbid
Postoperative Pain
Postoperative Nausea and Vomiting
Drug: Gabapentin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Effect of preoperative and postoperative administration of gabapentin on postoperative opioid requirement. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Effect of preoperative and postoperative administration of gabapentin on incidence of postoperative nausea and vomiting. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effective of preoperative and postoperative Gabapentin on the incidence of respiratory depression as evidenced by pulse oximetry data [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Preoperative Gabapentin Liquid
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Drug: Gabapentin
Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
Experimental: 2 Preoperative and Postoperative Gabapentin Liquid
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Drug: Gabapentin
Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
Placebo Comparator: 3 Preoperative and Postoperative Placebo Liquid
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Drug: Placebo
Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)

Detailed Description:

The occurrence of morbid obesity is at epidemic proportions in the United States. Laparoscopic gastric bypass is an effective means of safely facilitating patient weight loss and thereby drastically reducing the prevalence and severity of many future health complications [1]. However, managing morbidly obese surgical patients poses certain obstacles for anesthesiologists, including a high incidence of obstructive sleep apnea [2].

Laparoscopic gastric bypass, like all surgical interventions, has associated postoperative challenges including pain management and prevention/control of postoperative nausea and vomiting. To assure the highest patient satisfaction, all areas of patient comfort must be addressed. However, with pain management in morbidly obese patients, caution must be used when administering opioids, as they can have an increasing effect of respiratory depression in patients already at risk due to obstructive sleep apnea [3]. Gastric bypass is also associated with a significant incidence of protracted postoperative nausea and vomiting [4]. Therefore, regimens that address both patient safety and patient comfort are desired.

Gabapentin (Neurontin) is an alkylated analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that has been FDA approved for the treatment of seizures, headaches fibromyalgia and chronic neuropathic pain due to various etiologies [5]. Many randomized controlled trials have been performed with perioperative gabapentin [6-10]. The effect of perioperative administration of gabapentin on postoperative pain and opioid consumption has been extensively studied and several meta-analyses have been published in the last several years examining to overall findings of these studies. The general consensus is that gabapentin has anti-hyperalgesic and opioid-sparing properties and may also reduce the incidence of postoperative nausea and vomiting [5, 11-15]. Most research has shown that gabapentin is beneficial in the treatment of postoperative pain, but some show neither positive nor negative effects. There has been no evidence that gabapentin is detrimental or poses any risks to the postoperative patient. However, gabapentin has not been specifically studied in bariatric surgery. Therefore, the purpose of this study is to explore the hypothesis that perioperative gabapentin has anti-hyperalgesic and opioid-sparing properties, thus increase patient comfort and satisfaction by decreasing pain scores and reducing the adverse effects of opioids, such as postoperative nausea and vomiting.

This is a randomized, double-blind and placebo controlled study, which will be performed in adult laparoscopic gastric bypass patients coming to surgery for morbid obesity. The major end-points of analyses are intraoperative and postoperative opioid requirements and the incidence of nausea and vomiting in the postoperative period.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic gastric bypass surgery
  • Age > 18 years

Exclusion Criteria:

  • Patients under the age of 18 years
  • Patients who undergo open gastric bypass
  • Patients with a history of chronic pain treated with pregabalin, gabapentin or opioids
  • Patients with a history of chronic renal disease (creatinine > 1.3)
  • Patients with a history of bleeding gastric ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886236

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Matthew D McEvoy, MD Medical University of South Carolina
  More Information

Publications:

Responsible Party: Matthew D. McEvoy, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00886236     History of Changes
Other Study ID Numbers: HR # 18041 Gaba Bariatric
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Gastric Bypass
Gabapentin
Postoperative Nausea and Vomiting
Analgesics, Opioids
Sleep Apnea, Obstructive
Respiratory Depression
Oximetry

Additional relevant MeSH terms:
Nausea
Obesity, Morbid
Pain, Postoperative
Postoperative Nausea and Vomiting
Vomiting
Body Weight
Nutrition Disorders
Obesity
Overnutrition
Overweight
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents

ClinicalTrials.gov processed this record on October 20, 2014