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Gabapentin to Reduce Postoperative Nausea and Vomiting

K

Khon Kaen University

Status and phase

Completed
Phase 4

Conditions

Postoperative Nausea and Vomiting

Treatments

Drug: Gabapentin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02944981
HE571129

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Gabapentin
Experimental group
Description:
Patient receiving oral gabapentin 600 mg preoperatively
Treatment:
Drug: Gabapentin
Placebo
Placebo Comparator group
Description:
Patient receiving oral placebo tablet preoperatively
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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