Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:43 AM
Study NCT ID:
NCT04068506
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effects of Gabapentin and Paracetamol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-02-20', 'releaseDate': '2020-02-04'}, {'resetDate': '2020-03-06', 'releaseDate': '2020-02-25'}, {'resetDate': '2020-04-01', 'releaseDate': '2020-03-20'}], 'estimatedResultsFirstSubmitDate': '2020-02-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of analgesic effects of Gabapentin and paracetamol in patients with hand injury', 'timeFrame': '6 months', '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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Injuries']}, 'referencesModule': {'references': [{'pmid': '34783725', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/books/NBK2658/', 'label': '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', 'label': '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', 'label': '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/', 'label': 'Gabapentin in Acute Postoperative Pain Management'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/12198050', 'label': 'Pain as a factor complicating recovery and discharge after ambulatory surgery.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567599/', 'label': 'Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346867/', 'label': 'Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThis 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.\n\nSample 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n 1. Patients between 18-60 years of age\n 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\n2. Exclusion criteria:\n\n 1. Pregnant women\n 2. Any patient presenting with the signs of:\n\n * Arrhythmia\n * Myocardial ischemia\n * Cognitive impairment\n * Psychiatric disorders\n * Drug abuse\n 3. Patients sensitive to any epileptic drug or taking any anti-epileptic drug\n 4. Having severe and multiple injuries.'}, 'identificationModule': {'nctId': 'NCT04068506', 'acronym': 'GABA', 'briefTitle': 'Analgesic Effects of Gabapentin and Paracetamol', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Gabapentin 600 mg Tab', 'interventionNames': ['Drug: Gabapentin 600 mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Paracetamol 1000 mg Tab', 'interventionNames': ['Drug: Gabapentin 600 mg Tab']}], 'interventions': [{'name': 'Gabapentin 600 mg Tab', 'type': 'DRUG', 'otherNames': ['Neurontin'], 'description': 'Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dr. Ruth K.M. Pfau Civil Hospital Karachi', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Hyder Ali, MBBS,FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor at Dr.Ruth K.M pfau Civil Hospital Karachi,DUHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Hyder Ali', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-04', 'type': 'RELEASE'}, {'date': '2020-02-20', 'type': 'RESET'}, {'date': '2020-02-25', 'type': 'RELEASE'}, {'date': '2020-03-06', 'type': 'RESET'}, {'date': '2020-03-20', 'type': 'RELEASE'}, {'date': '2020-04-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hyder Ali, assistant professor, Dow University of Health Sciences'}}}}