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

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ClinicalTrials.gov Identifier: NCT04491786
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Gia Dinh People Hospital

Tracking Information
First Submitted Date  ICMJE July 26, 2020
First Posted Date  ICMJE July 29, 2020
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE August 1, 2020
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
Consumption of morphine [ Time Frame: Postoperative 24 hours ]
Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2020)
Consumption of morphine [ Time Frame: Postoperative 24 hours ]
This is total consumption of morphine during postoperative 24 hours with PCA (mg)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
Side-effect [ Time Frame: Postoperative 24 hours ]
The rate of side-effect induced gabapentin, nefopam, and morphine
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2020)
Side-effect [ Time Frame: Postoperative 24 hours ]
This is incidence of side-effect induced gabapentin, nefopam, and morphine
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery
Official Title  ICMJE Department of Anaesthesiology
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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 nefopam
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Fusion
Intervention  ICMJE Drug: Gabapentin
Gabapentin plus nefopam
Other Name: Nefopam
Study Arms  ICMJE
  • 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
    Intervention: Drug: Gabapentin
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2021)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2020)
30
Actual Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age from 18 to 70.
  • Spinal selective surgery

Exclusion Criteria:

  • Allergy one of drugs in study.
  • Neurological disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04491786
Other Study ID Numbers  ICMJE GiaDinhPH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gia Dinh People Hospital
Study Sponsor  ICMJE Gia Dinh People Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Binh V. Huynh Nhan dan Gia Dinh Hospital
PRS Account Gia Dinh People Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP