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The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery

Sponsor
Gia Dinh People Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04491786
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The acute pain after spinal surgery is serious. The most pain is during 24 hours after surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.

Morphine is main analgesic to treat postoperative pain. However, some the side-effects can occur to patients and there are associate with dosage. So, some analgesics usually combinate with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...

Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't been reported yet.

The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of postoperative analgesia.

The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40% of the consumption of morphine during 24 hours.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

After enrolled, all participants will randomly assigned into the two groups. The intervention group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2 mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).

The efficacy of postoperative analgesia will evaluated with the consumption of morphine during 24 hours.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopamThe intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Department of Anaesthesiology
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GAPA

Participants will treated with preoperative 600 mg of gabapentin plus nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours

Drug: Gabapentin
Gabapentin plus nefopam
Other Names:
  • Nefopam

    		•
    No Intervention: Non-GAPA

    Participants will treated with nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours

    Outcome Measures

    Primary Outcome Measures

    1. Consumption of morphine [Postoperative 24 hours]

      Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)

    Secondary Outcome Measures

    1. Side-effect [Postoperative 24 hours]

      The rate of side-effect induced gabapentin, nefopam, and morphine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age from 18 to 70.

    • Spinal selective surgery

    Exclusion Criteria:

    • Allergy one of drugs in study.

    • Neurological disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Binh Huynh Ho Chi Minh City Ho Chi Minh Vietnam 70000

    Sponsors and Collaborators

    • Gia Dinh People Hospital

    Investigators

    • Study Chair: Binh V. Huynh, Nhan dan Gia Dinh Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gia Dinh People Hospital
    ClinicalTrials.gov Identifier:
    NCT04491786
    Other Study ID Numbers:
    • GiaDinhPH
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Gia Dinh People Hospital
    Gabapentin
    Nefopam
    Spinal surgery
    Postoperative analgesia
    Additional relevant MeSH terms:
    Gabapentin
    Nefopam

    Study Results

    No Results Posted as of Jun 7, 2021