Clinical trial NCT02944981: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postoperative nausea and vomiting (grade 1-3)
timeFrame: through study completion, an average of 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
name: Sirirat Tribuddharat, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.