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

Phase 1

Completed

• Conditions: Non-obstetric Lower Abdominal Surgery
• Interventions: Drug: Gabapentin; Other: Placebo

• Registration Number: NCT04434430
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-11-11
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Patient will receive preemptive oral gabapentin 600 mg
Placebo	Placebo	Patient will receive oral placebo

Primary Outcome Measures

Name	Time	Method
Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery	24 hours after surgery	Measured by total consumption of morphine on patient controlled analgesia machine
Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery	12 hours after surgery	Measured by total consumption of morphine on patient controlled analgesia machine
Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	2 hours after surgery	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.
Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	6 hours after surgery	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.
Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale	12 hours after surgery	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.
Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery	2 hours after surgery	Measured by total consumption of morphine on patient controlled analgesia machine
Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery	6 hours after surgery	Measured by total consumption of morphine on patient controlled analgesia machine

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia