Study Results
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Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2016-08-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Gabapentin
Patient receiving oral gabapentin 600 mg preoperatively
Gabapentin
Single oral dose
Placebo
Patient receiving oral placebo tablet preoperatively
Placebo
Single oral dose
Interventions
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Gabapentin
Single oral dose
Placebo
Single oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA physical status I-III
Exclusion Criteria
* Chronic use of narcotics
* Psychotic
* Bleeding disorder
* Cardiovascular disorder
* Liver or renal failure
* Pregnancy or breast feeding
* Neurologic disorder
18 Years
65 Years
ALL
Yes
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Thepakorn Sathitkarnmanee
Associate Professor
Principal Investigators
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Sirirat Tribuddharat, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Locations
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Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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HE571129
Identifier Type: -
Identifier Source: org_study_id
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