Clinical trial NCT00886236: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Postoperative Pain
Postoperative Nausea and Vomiting
Keywords: Gastric Bypass
Gabapentin
Postoperative Nausea and Vomiting
Analgesics, Opioids
Sleep Apnea, Obstructive
Respiratory Depression
Oximetry
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate the Amount of Diluadid Given Postoperatively
timeFrame: 120 hours
measure: Number of Participants Who Experience Incidence of Postoperative Nausea.
timeFrame: 120 hours
Secondary outcomes:
measure: Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data
timeFrame: 48 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Matthew D McEvoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Scott T Reeves, MD
role: STUDY_CHAIR
References:
citation: Sowemimo OA, Yood SM, Courtney J, Moore J, Huang M, Ross R, McMillian U, Ojo P, Reinhold RB. Natural history of morbid obesity without surgical intervention. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):73-7; discussion 77. doi: 10.1016/j.soard.2006.10.017. Epub 2006 Dec 27.
citation: Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.
citation: Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.
citation: Hofer RE, Sprung J, Sarr MG, Wedel DJ. Anesthesia for a patient with morbid obesity using dexmedetomidine without narcotics. Can J Anaesth. 2005 Feb;52(2):176-80. doi: 10.1007/BF03027725.
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citation: Pandey CK, Navkar DV, Giri PJ, Raza M, Behari S, Singh RB, Singh U, Singh PK. Evaluation of the optimal preemptive dose of gabapentin for postoperative pain relief after lumbar diskectomy: a randomized, double-blind, placebo-controlled study. J Neurosurg Anesthesiol. 2005 Apr;17(2):65-8. doi: 10.1097/01.ana.0000151407.62650.51.
citation: Fassoulaki A, Melemeni A, Stamatakis E, Petropoulos G, Sarantopoulos C. A combination of gabapentin and local anaesthetics attenuates acute and late pain after abdominal hysterectomy. Eur J Anaesthesiol. 2007 Jun;24(6):521-8. doi: 10.1017/S0265021506002134. Epub 2007 Jan 8.
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citation: Mathiesen O, Moiniche S, Dahl JB. Gabapentin and postoperative pain: a qualitative and quantitative systematic review, with focus on procedure. BMC Anesthesiol. 2007 Jul 7;7:6. doi: 10.1186/1471-2253-7-6.
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citation: Hurley RW, Cohen SP, Williams KA, Rowlingson AJ, Wu CL. The analgesic effects of perioperative gabapentin on postoperative pain: a meta-analysis. Reg Anesth Pain Med. 2006 May-Jun;31(3):237-47. doi: 10.1016/j.rapm.2006.01.005.
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