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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Department of Anaesthesiology

Conditions
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Spinal Fusion

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 70. Spinal selective surgery Exclusion Criteria: Allergy one of drugs in study. Neurological disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group will treated postoperative analgesia with 600 mg of gabapentin plus 65 mcg/kg/hour during 24 hours of nefopam
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAPA<br>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 | Drug: Gabapentin<br>* Gabapentin plus nefopam<br>* Other names: Nefopam;|
| No Intervention: Non-GAPA<br>Participants will treated with nefopam which will continuously transfused during intraoperative and postoperative 24 hours, and morphine-PCA during postoperative 24 hours | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of morphine | Concentration of morphine that participant use during postoperative 24 hours with PCA (mg) | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side-effect | The rate of side-effect induced gabapentin, nefopam, and morphine | Postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, Nefopam, Spinal surgery, Postoperative analgesia