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

Postoperative Pain Clinical Trial

Official title:

The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886236
• Other study ID #: HR # 18041 Gaba Bariatric
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Obesity, Morbid
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

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)
• 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)
• 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)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. Epub 2007 Jan 8. — View 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. — View Citation

Ho KY, Gan TJ, Habib AS. Gabapentin and postoperative pain--a systematic review of randomized controlled trials. Pain. 2006 Dec 15;126(1-3):91-101. Epub 2006 Jul 18. Review. — View 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. — View 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. — View Citation

Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. Review. — View Citation

Mathiesen O, Møiniche S, Dahl JB. Gabapentin and postoperative pain: a qualitative and quantitative systematic review, with focus on procedure. BMC Anesthesiol. 2007 Jul 7;7:6. — View Citation

Moussa AA, Oregan PJ. Prevention of postoperative nausea and vomiting in patients undergoing laparoscopic bariatric surgery--granisetron alone vs granisetron combined with dexamethasone/droperidol. Middle East J Anaesthesiol. 2007 Jun;19(2):357-67. — View 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. — View Citation

Prabhakar H, Arora R, Bithal PK, Rath GP, Dash HH. The analgesic effects of preemptive gabapentin in patients undergoing surgery for brachial plexus injury--a preliminary study. J Neurosurg Anesthesiol. 2007 Oct;19(4):235-8. — View Citation

Radhakrishnan M, Bithal PK, Chaturvedi A. Effect of preemptive gabapentin on postoperative pain relief and morphine consumption following lumbar laminectomy and discectomy: a randomized, double-blinded, placebo-controlled study. J Neurosurg Anesthesiol. 2005 Jul;17(3):125-8. — View Citation

Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. — View 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. Epub 2006 Dec 27. — View Citation

Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. Review. — View Citation

Turan A, Karamanlioglu B, Memis D, Usar P, Pamukçu Z, Türe M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Amount of Diluadid Given Postoperatively	The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.	120 hours
Primary	Number of Participants Who Experience Incidence of Postoperative Nausea.		120 hours
Secondary	Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data		48 hours