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

NCT04491786 | Completed

• 1 other identifier: GiaDinhPH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion

Keywords

Gabapentin; Nefopam; Spinal surgery; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Consumption of morphine

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

  Postoperative 24 hours

Secondary Outcomes (1)

• Side-effect

  Postoperative 24 hours

Study Arms (2)

GAPA

EXPERIMENTAL

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

Non-GAPA

NO INTERVENTION

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

Interventions

Gabapentin DRUG

Gabapentin plus nefopam

Also known as: Nefopam

GAPA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70.
• Spinal selective surgery

You may not qualify if:

• Allergy one of drugs in study.
• Neurological disorder.

Sponsors & Collaborators

• Gia Dinh People Hospital: lead

Study Sites (1)

Binh Huynh

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

Location

MeSH Terms

Interventions

Gabapentin; Nefopam

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Binh V. Huynh

  Nhan dan Gia Dinh Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 31, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-01

Locations

VN (1)