Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Study Overview
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Brief Summary
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This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

Detailed Description
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Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.

Official Title
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Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Conditions
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Non-obstetric Lower Abdominal Surgery

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female Age: 18-65 years old Weigh in range around 20% of the ideal body weight Physical status ASA I-II Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia Duration of surgery less than 4 hours Patients who agreed to participate in this study and sign informed consent Exclusion criteria: Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids Patients who consumed analgesia and NSAID less than 12 hours before surgery Patients who experienced physical trauma less than 4 days before surgery Patients who have contraindications to gabapentin, morphine, and paracetamol Patients who were treated with neuraxial block or peripheral nerve block before and during surgery Patients who have history of diabetes, severe live or renal disease Patients who were treated with antihypertension, sedatives, hypnotics, antidepressants, and the other drugs that have effects on nervous system Patients who have psychiatric disorders Patients who consumed gabapentin before perioperative period Pregnant or breastfeeding patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>Patient will receive preemptive oral gabapentin 600 mg | Drug: Gabapentin<br>* Oral Gabapentin 600 mg<br>|
| Placebo Comparator: Placebo<br>Patient will receive oral placebo | Other: Placebo<br>* Oral NaCl 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery | Measured by total consumption of morphine on patient controlled analgesia machine | 24 hours after surgery | 
| Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale | Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale | Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is. | 2 hours after surgery | 
| Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale | Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is. | 6 hours after surgery | 
| Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale | Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is. | 12 hours after surgery | 
| Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery | Measured by total consumption of morphine on patient controlled analgesia machine | 2 hours after surgery | 
| Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery | Measured by total consumption of morphine on patient controlled analgesia machine | 6 hours after surgery | 
| Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery | Measured by total consumption of morphine on patient controlled analgesia machine | 12 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preemptive analgesia, gabapentin, morphine, lower abdominal surgery