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

NCT ID: NCT04491786

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-05-31

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.

Conditions

Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

Gabapentin plus nefopam

Non-GAPA

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gabapentin

Gabapentin plus nefopam

Intervention Type: DRUG

Other Intervention Names

Nefopam

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 70.
• Spinal selective surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gia Dinh People Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binh V. Huynh

Role: STUDY_CHAIR

Nhan dan Gia Dinh Hospital

Locations

Binh Huynh

Ho Chi Minh City, Ho Chi Minh, Vietnam

Countries

Vietnam

Other Identifiers

GiaDinhPH

Identifier Type: -

Identifier Source: org_study_id