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

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

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

Study Overview

• Status: Completed
• Conditions: Non-obstetric Lower Abdominal Surgery
• Intervention / Treatment: Drug: Gabapentin; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patient will receive oral placebo	Other: Placebo; Oral NaCl 500 mg
Active Comparator: Gabapentin; Patient will receive preemptive oral gabapentin 600 mg	Drug: Gabapentin; Oral Gabapentin 600 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.
• Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
• Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
• Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
• Shavit Y, Fridel K, Beilin B. Postoperative pain management and proinflammatory cytokines: animal and human studies. J Neuroimmune Pharmacol. 2006 Dec;1(4):443-51. doi: 10.1007/s11481-006-9043-1. Epub 2006 Sep 29.
• Beilin B, Shavit Y, Trabekin E, Mordashev B, Mayburd E, Zeidel A, Bessler H. The effects of postoperative pain management on immune response to surgery. Anesth Analg. 2003 Sep;97(3):822-827. doi: 10.1213/01.ANE.0000078586.82810.3B.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: morphine; preemptive analgesia; lower abdominal surgery; gabapentin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: IndonesiaUAnes 054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No