Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting
Overview[ - collapse ][ - ]
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 | Obesity, Morbid Postoperative Pain Postoperative Nausea and Vomiting |
Intervention | Drug: Gabapentin Drug: Placebo Drug: Gabapentin |
Phase | N/A |
Sponsor | Medical University of South Carolina |
Responsible Party | Medical University of South Carolina |
ClinicalTrials.gov Identifier | NCT00886236 |
First Received | April 21, 2009 |
Last Updated | April 21, 2009 |
Last verified | April 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | April 21, 2009 |
---|---|
Last Updated Date | April 21, 2009 |
Start Date | July 2008 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures |
|
Current 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] |
Descriptive Information[ + expand ][ + ]
Brief Title | Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting |
---|---|
Official Title | The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients |
Brief Summary | 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. |
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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
|
Intervention | 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) 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) 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) |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
---|---|
Estimated Enrollment | 150 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00886236 |
---|---|
Other Study ID Numbers | HR # 18041 Gaba Bariatric |
Has Data Monitoring Committee | No |
Information Provided By | Medical University of South Carolina |
Study Sponsor | Medical University of South Carolina |
Collaborators | Not Provided |
Investigators | Principal Investigator: Matthew D McEvoy, MD Medical University of South Carolina |
Verification Date | April 2009 |
Locations[ + expand ][ + ]
Medical University of South Carolina | Charleston, South Carolina, United States, 29425 |
---|