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

NCT04434430 | Completed Phase 1 DMC

• 1 other identifier: IndonesiaUAnes 054
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Non-obstetric Lower Abdominal Surgery

Keywords

preemptive analgesia; gabapentin; morphine; lower abdominal surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale

  2 hours after surgery

• Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale

  6 hours after surgery

• Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale

  12 hours after surgery

• Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery

  2 hours after surgery

• Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery

  6 hours after surgery

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Patient will receive preemptive oral gabapentin 600 mg

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Patient will receive oral placebo

Other: Placebo

Interventions

Gabapentin DRUG

Oral Gabapentin 600 mg

Gabapentin

Placebo OTHER

Oral NaCl 500 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (6)

• 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.

  PMID: 18582931 RESULT

• Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.

  PMID: 26526062 RESULT

• 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.

  PMID: 19672167 RESULT

• 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.

  PMID: 18040817 RESULT

• 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.

  PMID: 12933409 RESULT

• 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.

  PMID: 23703420 RESULT

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 16, 2020
• Study Start: November 11, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)