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NCT Number: NCT02944981

Gabapentin to Reduce Postoperative Nausea and Vomiting

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Single oral dose

Other names: Neurontin

Placebo

Drug

Single oral dose

Other names: Sugar pill

Primary outcomes

  1. Postoperative nausea and vomiting (grade 1-3)

    Time frame: through study completion, an average of 24 hours

    PONV grading: 0 = none; 1 = mild; 2 = moderate; 3 = severe

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Gabapentin Premedication to Reduce Postoperative Nausea and Vomiting in Surgical Patient Receiving Spinal Morphine

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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