Analgesic Effects of Gabapentin and Paracetamol

Hand Injuries Clinical Trial

— GABA  

Official title:

Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068506
• Other study ID #: 123
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: January 21, 2020

Study information

• Verified date: January 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 21, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Injuries

Intervention

Drug:
• Gabapentin 600 mg Tab
Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.

Locations

Country	Name	City	State
Pakistan	Dr. Ruth K.M. Pfau Civil Hospital Karachi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury	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.	6 months

External Links

•   A descriptive study of hand injuries presenting to the adult emergency department of a tertiary care center in urban India.
•   Examination of the evidence for off-label use of gabapentin.
•   Gabapentin in Acute Postoperative Pain Management
•   Improving the Quality of Care Through Pain Assessment and Management.
•   Pain as a factor complicating recovery and discharge after ambulatory surgery.
•   Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged.
•   Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists
•   Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection
•   The Anticonvulsant, Antihyperalgesic Agent Gabapentin Is an Agonist at Brain ?-Aminobutyric Acid Type B Receptors Negatively Coupled to Voltage-Dependent Calcium Channels