NCT02944981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

October 25, 2016

Last Update Submit

May 10, 2017

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomiting (grade 1-3)

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

    through study completion, an average of 24 hours

Study Arms (2)

Gabapentin

EXPERIMENTAL

Patient receiving oral gabapentin 600 mg preoperatively

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Patient receiving oral placebo tablet preoperatively

Drug: Placebo

Interventions

GabapentinDRUG

Single oral dose

Also known as: Neurontin
Gabapentin
PlaceboDRUG

Single oral dose

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing general or regional anesthesia receiving spinal morphine
  • ASA physical status I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 10598635RESULT

  • 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.

    PMID: 12670812RESULT

  • 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.

    PMID: 16679671RESULT

  • 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.

    PMID: 15275765RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

GabapentinSugars

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Sirirat Tribuddharat, MD

    Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 26, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)