search
Back to results

Analgesic Effects of Gabapentin and Paracetamol (GABA)

Primary Purpose

Hand Injuries

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Gabapentin 600 mg Tab
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hand Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  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.

Sites / Locations

  • Dr. Ruth K.M. Pfau Civil Hospital Karachi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Gabapentin 600 mg Tab

Paracetamol 1000 mg Tab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2018
Last Updated
January 22, 2020
Sponsor
Dow University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04068506
Brief Title
Analgesic Effects of Gabapentin and Paracetamol
Acronym
GABA
Official Title
Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 7, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators will divide the calculated sample size into two groups A and B in which all the participants have the same probability of being included in the study. Two unrecognizable envelopes separating both drugs gabapentin and paracetamol with equivalent dose will be administered with the specific code number labeled by the principal investigator and will be prescribed by the on-duty doctor to the patients in tablet form once orally allowed after surgery. Analgesic effects will be inquired after 6 hours of drug administration. Further questions will be asked according to the questionnaire by the co-investigators having no knowledge of the given drug to participant.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Gabapentin 600 mg Tab
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Paracetamol 1000 mg Tab
Intervention Type
Drug
Intervention Name(s)
Gabapentin 600 mg Tab
Other Intervention Name(s)
Neurontin
Intervention Description
Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.
Primary Outcome Measure Information:
Title
Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 18-60 years of age Patients Undergoing hand surgery in the Department of Plastics and Reconstructive Surgery, Dr. Ruth KM Pfau Civil Hospital Karachi, Dow University of Health Sciences Exclusion criteria: Pregnant women Any patient presenting with the signs of: Arrhythmia Myocardial ischemia Cognitive impairment Psychiatric disorders Drug abuse Patients sensitive to any epileptic drug or taking any anti-epileptic drug Having severe and multiple injuries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyder Ali, MBBS,FCPS
Organizational Affiliation
Assistant professor at Dr.Ruth K.M pfau Civil Hospital Karachi,DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ruth K.M. Pfau Civil Hospital Karachi
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34783725
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/books/NBK2658/
Description
Improving the Quality of Care Through Pain Assessment and Management.
URL
http://www.onlinejets.org/article.asp?issn=0974-2700;year=2017;volume=10;issue=1;spage=19;epage=25;aulast=Ghiya
Description
A descriptive study of hand injuries presenting to the adult emergency department of a tertiary care center in urban India.
URL
https://www.ncbi.nlm.nih.gov/pubmed/12873949
Description
Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4009126/
Description
Gabapentin in Acute Postoperative Pain Management
URL
https://www.ncbi.nlm.nih.gov/pubmed/12198050
Description
Pain as a factor complicating recovery and discharge after ambulatory surgery.
URL
http://jpet.aspetjournals.org/content/298/1/15.long
Description
The Anticonvulsant, Antihyperalgesic Agent Gabapentin Is an Agonist at Brain γ-Aminobutyric Acid Type B Receptors Negatively Coupled to Voltage-Dependent Calcium Channels
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567599/
Description
Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists
URL
https://www.jmcp.org/doi/10.18553/jmcp.2003.9.6.559
Description
Examination of the evidence for off-label use of gabapentin.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346867/
Description
Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection

Learn more about this trial

Analgesic Effects of Gabapentin and Paracetamol

We'll reach out to this number within 24 hrs