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

Not Applicable

Completed

• Conditions: Spinal Fusion
• Interventions: Drug: Gabapentin

• Registration Number: NCT04491786
• Lead Sponsor: Gia Dinh People Hospital

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 Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Study Start: 2020-08-01
• Status Verified: 2021-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age from 18 to 70.
• Spinal selective surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GAPA	Gabapentin	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

Primary Outcome Measures

Name	Time	Method
Consumption of morphine	Postoperative 24 hours	Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)

Secondary Outcome Measures

Name	Time	Method
Side-effect	Postoperative 24 hours	The rate of side-effect induced gabapentin, nefopam, and morphine

Trial Locations

Locations (1)

Binh Huynh; 🇻🇳 Ho Chi Minh City, Ho Chi Minh, Vietnam