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Completed

NCT Number: NCT04491786

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

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.

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Key information

Conditions

Spinal Fusion

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binh Huynh

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 70.
  • Spinal selective surgery

Exclusion criteria

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

Treatment and study plan

Gabapentin

Drug

Gabapentin plus nefopam

Other names: Nefopam

Primary outcomes

  1. Consumption of morphine

    Time frame: Postoperative 24 hours

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

Secondary outcomes

  1. Side-effect

    Time frame: Postoperative 24 hours

    The rate of side-effect induced gabapentin, nefopam, and morphine

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

Department of Anaesthesiology

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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