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

Spinal Fusion Clinical Trial

Official title:

Department of Anaesthesiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491786
• Other study ID #: GiaDinhPH
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2021
• Source: Gia Dinh People Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 70.

• Spinal selective surgery

Exclusion Criteria:

• Allergy one of drugs in study.

• Neurological disorder.

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Drug:
• Gabapentin
Gabapentin plus nefopam

Locations

Country	Name	City	State
Vietnam	Binh Huynh	Ho Chi Minh City	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of morphine	Concentration of morphine that participant use during postoperative 24 hours with PCA (mg)	Postoperative 24 hours
Secondary	Side-effect	The rate of side-effect induced gabapentin, nefopam, and morphine	Postoperative 24 hours