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

NCT00886236 | Completed Results

• 1 other identifier: HR # 18041 Gaba Bariatric
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants Who Experience Incidence of Postoperative Nausea.

  120 hours

Secondary Outcomes (1)

• Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data

  48 hours

Study Arms (3)

1 Preoperative Gabapentin Liquid

ACTIVE COMPARATOR

Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)

Drug: Gabapentin

2 Preoperative and Postoperative Gabapentin Liquid

EXPERIMENTAL

Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)

Drug: Gabapentin

3 Preoperative and Postoperative Placebo Liquid

PLACEBO COMPARATOR

Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)

Drug: Placebo

Interventions

Gabapentin DRUG

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)

2 Preoperative and Postoperative Gabapentin Liquid

Placebo DRUG

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)

3 Preoperative and Postoperative Placebo Liquid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (15)

• 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.

  PMID: 17196439 BACKGROUND

• 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.

  PMID: 16517328 BACKGROUND

• Kong VK, Irwin MG. Gabapentin: a multimodal perioperative drug? Br J Anaesth. 2007 Dec;99(6):775-86. doi: 10.1093/bja/aem316.

  PMID: 18006529 BACKGROUND

• 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.

  PMID: 15684259 BACKGROUND

• 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.

  PMID: 17684876 BACKGROUND

• Turan A, Karamanlioglu B, Memis D, Usar P, Pamukcu Z, Ture M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents. doi: 10.1213/01.ane.0000108964.70485.b2.

  PMID: 15105217 BACKGROUND

• 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. doi: 10.1097/ANA.0b013e3181271863.

  PMID: 17893574 BACKGROUND

• 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.

  PMID: 15840990 BACKGROUND

• 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.

  PMID: 17207299 BACKGROUND

• 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. doi: 10.1097/01.ana.0000167147.90544.ab.

  PMID: 16037731 BACKGROUND

• 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.

  PMID: 17617920 BACKGROUND

• 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. doi: 10.1016/j.pain.2006.06.018. Epub 2006 Jul 18.

  PMID: 16846695 BACKGROUND

• 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.

  PMID: 16701190 BACKGROUND

• Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.

  PMID: 16636030 BACKGROUND

• 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. doi: 10.1213/01.ane.0000261517.27532.80.

  PMID: 17513656 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative; Postoperative Nausea and Vomiting; Sleep Apnea, Obstructive; Respiratory Insufficiency

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Larry Field
• Organization: Medical University of South Carolina

field@musc.edu

843-876-5744

Study Officials

• Matthew D McEvoy, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Scott T Reeves, MD

  Medical University of South Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: February 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-08

Locations

US (1)