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

Department of Anaesthesiology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04491786
Enrollment
60
Registered
2020-07-29
Start date
2020-08-01
Completion date
2021-05-31
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion

Keywords

Gabapentin, Nefopam, Spinal surgery, Postoperative analgesia

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.

Interventions

DRUGGabapentin

Gabapentin plus nefopam

Sponsors

Gia Dinh People Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Age from 18 to 70. * Spinal selective surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Consumption of morphinePostoperative 24 hoursConcentration of morphine that participant use during postoperative 24 hours with PCA (mg)

Secondary

MeasureTime frameDescription
Side-effectPostoperative 24 hoursThe rate of side-effect induced gabapentin, nefopam, and morphine

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026