Postoperative Pain Clinical Trial
Official title:
The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients
Verified date | August 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
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
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 |
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