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Analgesic Effects of Gabapentin and Paracetamol (GABA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068506
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hyder Ali, Dow University of Health Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hand Injuries Drug: Gabapentin 600 mg Tab Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : January 7, 2020
Actual Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Gabapentin 600 mg Tab
 Drug: Gabapentin 600 mg Tab
Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.
Other Name: Neurontin
Active Comparator: Group B
Paracetamol 1000 mg Tab
 Drug: Gabapentin 600 mg Tab
Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.
Other Name: Neurontin


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068506


Locations
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Pakistan
Dr. Ruth K.M. Pfau Civil Hospital Karachi
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Principal Investigator: Hyder Ali, MBBS,FCPS Assistant professor at Dr.Ruth K.M pfau Civil Hospital Karachi,DUHS
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyder Ali, assistant professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04068506    
Other Study ID Numbers: 123
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hand Injuries
Wounds and Injuries
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents