Gabapentin to Reduce Postoperative Nausea and Vomiting
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing general or regional anesthesia receiving spinal morphine
- ASA physical status I-III
Exclusion Criteria:
- Patients with allergy to morphine or gabapentin
- Chronic use of narcotics
- Psychotic
- Bleeding disorder
- Cardiovascular disorder
- Liver or renal failure
- Pregnancy or breast feeding
- Neurologic disorder
Sites / Locations
- Faculty of Medicine, Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Patient receiving oral gabapentin 600 mg preoperatively
Patient receiving oral placebo tablet preoperatively
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting (grade 1-3)
PONV grading: 0 = none; 1 = mild; 2 = moderate; 3 = severe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02944981
Brief Title
Gabapentin to Reduce Postoperative Nausea and Vomiting
Official Title
Gabapentin Premedication to Reduce Postoperative Nausea and Vomiting in Surgical Patient Receiving Spinal Morphine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The intrathecal administration of morphine is gaining popularity. It is easy to do and can reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and vomiting more than other methods providing postoperative analgesia. Patients suffering from these side effects have to spend a longer period of time recovering in the hospital with high cost of medical treatment.
Detailed Description
Objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine.
Methods: Eighty patients undergoing orthopedic surgery and receiving intrathecal morphine will be randomized into 2 groups. The first group will receive oral gabapentin 600 mg and the second group will receive a placebo tablet. Both groups will receive a standard prophylactic medication for postoperative nausea and vomiting. The degrees of nausea and vomiting in both groups will be assessed over 24 hours postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Patient receiving oral gabapentin 600 mg preoperatively
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient receiving oral placebo tablet preoperatively
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
Single oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Single oral dose
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting (grade 1-3)
Description
PONV grading: 0 = none; 1 = mild; 2 = moderate; 3 = severe
Time Frame
through study completion, an average of 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing general or regional anesthesia receiving spinal morphine
ASA physical status I-III
Exclusion Criteria:
Patients with allergy to morphine or gabapentin
Chronic use of narcotics
Psychotic
Bleeding disorder
Cardiovascular disorder
Liver or renal failure
Pregnancy or breast feeding
Neurologic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirirat Tribuddharat, MD
Organizational Affiliation
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10598635
Citation
Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
Results Reference
result
PubMed Identifier
12670812
Citation
Devys JM, Mora A, Plaud B, Jayr C, Laplanche A, Raynard B, Lasser P, Debaene B. Intrathecal + PCA morphine improves analgesia during the first 24 hr after major abdominal surgery compared to PCA alone. Can J Anaesth. 2003 Apr;50(4):355-61. doi: 10.1007/BF03021032. English, French.
Results Reference
result
PubMed Identifier
16679671
Citation
Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.
Results Reference
result
PubMed Identifier
15275765
Citation
Rorarius MG, Mennander S, Suominen P, Rintala S, Puura A, Pirhonen R, Salmelin R, Haanpaa M, Kujansuu E, Yli-Hankala A. Gabapentin for the prevention of postoperative pain after vaginal hysterectomy. Pain. 2004 Jul;110(1-2):175-81. doi: 10.1016/j.pain.2004.03.023.
Results Reference
result
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Gabapentin to Reduce Postoperative Nausea and Vomiting
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