Clinical trial NCT04068506: Analgesic Effects of Gabapentin and Paracetamol
Official title: Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Injuries
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 50 patients who fulfill the inclusion criteria will be approached and written consent will be signed by the participants prior to the interview. Participants will be divided into two groups divided equally i.e. gabapentin group and paracetamol group. Gabapentin group received 600 mg dose while the control/other group received 1 gram (1000 mg) of paracetamol as a postoperative analgesic agent.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 1. 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.

Primary outcomes:
measure: Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ruth K.M. Pfau Civil Hospital Karachi
state: Sindh
Study officials:
affiliation: Assistant professor at Dr.Ruth K.M pfau Civil Hospital Karachi,DUHS
name: Hyder Ali, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ali H; Naveed; Perveen B. Comparison of analgesic effects of Gabapentin and Paracetamol post-operatively in patients with hand injury. J Pak Med Assoc. 2021 Nov;71(11):2501-2505. doi: 10.47391/JPMA.359.