Analgesic Effects of Gabapentin and Paracetamol

Phase 4

Completed

• Conditions: Hand Injuries
• Interventions: Drug: Gabapentin 600 mg Tab

• Registration Number: NCT04068506
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

This research is about the effects of drug gabapentin; which is an amino acid that is structurally similar to neurotransmitter GABA. It is a novel drug used for the treatment of postoperative pain with analgesic properties having unique mechanism of action. This study reviews clinical effects of this agent in hand injury patients managed at the Department of Plastics \& Reconstructive Surgery, Dow University of Health Sciences \& Dr. Ruth KM Pfau Civil Hospital Karachi.

This study aims to inquire the analgesic properties of gabapentin in the patients and to further investigate its comparison with the equivalent dose of paracetamol given 6 hours after undergoing operative procedure. Acetaminophen is well tolerated when administered in therapeutic dose for pain management. It is a principal drug used as pain reliever and as an antipyretic regimen.

This is an experimental study in which a pre-coded questionnaire would be approved in the research for appraising the intensity of pain after intervening operative procedure using visual analogue scale, measuring the pain intensity from 0-10. The questions regarding pain intensity will be inquired after administrating the drug six hours postoperatively. The drug will be prescribed by the doctor on duty having no knowledge regarding the given drug or the group in which he/she is administrating the drug; further questionnaire will be filled by the two co-investigators who will be trained by principal investigator, how to take correct information.

Sample size was calculated using www.openepi.com using the previous literature searches of similar research and 50 patients (25 in each group) will be randomly selected from the ward of a known case of hand injury. Group A patients will receive 600 mg of gabapentin post operatively while group B will receive 1 g of paracetamol for management of pain postoperatively orally.

Detailed Description

Gabapentin is an anti-convulsion medication and has a high affinity for voltage-gated calcium channel throughout the brain, acts by inhibition of release of excitatory neurotransmitters. As a lipophilic substance, it shows linear pharmacokinetics and has oral bioavailability greater than 90%. Gabapentin is used in a variety of condition as a therapeutic measure involving diabetic neuropathy, post-herpetic neuralgia, in partial seizures, restless leg syndrome, post-menopausal hot flashes, anxiety, resistant mood disorders, essential tremors, and numerous other modalities. Gabapentin is a muscle relaxant and anti-spasmodic, its analgesic effect has also be identified for moderate to severe pain.

Study Timeline

• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-09-01
• Status Verified: 2020-01
• Primary Completion: 2020-01-07
• Study Completion: 2020-01-21
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Patients between 18-60 years of age 2. Patients Undergoing hand surgery in the Department of Plastics and Reconstructive Surgery, Dr. Ruth KM Pfau Civil Hospital Karachi, Dow University of Health Sciences

2. Exclusion criteria:

   1. Pregnant women

   2. Any patient presenting with the signs of:

      • Arrhythmia
      • Myocardial ischemia
      • Cognitive impairment
      • Psychiatric disorders
      • Drug abuse

   3. Patients sensitive to any epileptic drug or taking any anti-epileptic drug

   4. Having severe and multiple injuries.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Gabapentin 600 mg Tab	Gabapentin 600 mg Tab
Group B	Gabapentin 600 mg Tab	Paracetamol 1000 mg Tab

Primary Outcome Measures

Name	Time	Method
Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury	6 months	The outcome of this study will be finding that how much gabapentin is effective in improving pain over paracetamol by simply inquiring about the analgesic effect of both drugs with the help of Visual analogue scale measuring pain intensity from 1 - 10 and how much each drug adversely effects individual's health by assessment of any unwanted symptoms like: nausea, vomiting, headache, dizziness, etc. So, that certainty about its effect and efficacy over paracetamol in relieving pain can be assessed.

Trial Locations

Locations (1)

Dr. Ruth K.M. Pfau Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan