Ignite Creation Date:
2024-05-05 @ 9:27 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00886236
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2009-04-21
Brief Title:
Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 preventioncontrol 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
Laparoscopic gastric bypass like all surgical interventions has associated postoperative challenges including pain management and preventioncontrol 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None