Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-03 @ 3:13 PM
Study NCT ID:
NCT06608056
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale - pain score', 'timeFrame': '2-, 6-, 12-, 24-hours following surgery', 'description': 'Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).'}], 'secondaryOutcomes': [{'measure': 'Flatus', 'timeFrame': 'within 24 hours following surgery', 'description': 'Time to passing flatus'}, {'measure': 'nausea/vomiting', 'timeFrame': 'within 24 hours following surgery', 'description': 'time when nausea/vomiting was not present in the patient'}, {'measure': 'Time to ambulation', 'timeFrame': 'within 24 hours following surgery', 'description': 'time after surgery when the patient started ambulating'}, {'measure': 'rescue analgesia', 'timeFrame': 'within 24 hours following surgery', 'description': 'number of times rescue analgesia was used'}, {'measure': 'Mean arterial pressure', 'timeFrame': '2-, 6-, 12-, 24-hours following surgery', 'description': 'systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated'}, {'measure': 'Heart rate', 'timeFrame': '2-, 6-, 12-, 24 hours', 'description': 'Heart rate was measured at intervals in beats per minute'}, {'measure': 'oxygen saturation', 'timeFrame': '2-, 6-, 12-, 24 hours', 'description': 'oxygen saturation was noted at intervals'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lichtenstein repair', 'ketorolac', 'tramadol', 'opioid', 'visual analogue score', 'non-steroidal anti-inflammatory drugs'], 'conditions': ['Inguinal Hernia Unilateral', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '26329661', 'type': 'BACKGROUND', 'citation': "Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30."}, {'type': 'BACKGROUND', 'citation': 'Zende, A.M. and R.R. Bhosale, Comparison of postoperative analgesic efficacy and safety of parecoxib and ketorolac in patients of inguinal hernia. International Journal of Basic and Clinical Pharmacology, 2013. 2(4): p. 414-20.'}, {'pmid': '30211382', 'type': 'BACKGROUND', 'citation': 'Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.'}, {'pmid': '21965355', 'type': 'BACKGROUND', 'citation': 'De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.'}, {'pmid': '11273941', 'type': 'BACKGROUND', 'citation': 'Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. doi: 10.1097/00000539-200104000-00038.'}, {'pmid': '15777304', 'type': 'BACKGROUND', 'citation': 'Chen JY, Wu GJ, Mok MS, Chou YH, Sun WZ, Chen PL, Chan WS, Yien HW, Wen YR. Effect of adding ketorolac to intravenous morphine patient-controlled analgesia on bowel function in colorectal surgery patients--a prospective, randomized, double-blind study. Acta Anaesthesiol Scand. 2005 Apr;49(4):546-51. doi: 10.1111/j.1399-6576.2005.00674.x.'}, {'pmid': '29023083', 'type': 'BACKGROUND', 'citation': 'National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK458660/'}, {'pmid': '17072916', 'type': 'BACKGROUND', 'citation': 'Goettsch WG, Sukel MP, van der Peet DL, van Riemsdijk MM, Herings RM. In-hospital use of opioids increases rate of coded postoperative paralytic ileus. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):668-74. doi: 10.1002/pds.1338.'}, {'pmid': '21730280', 'type': 'BACKGROUND', 'citation': 'Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.'}, {'pmid': '24436674', 'type': 'BACKGROUND', 'citation': 'Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.'}, {'pmid': '11460814', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.'}, {'pmid': '10376632', 'type': 'BACKGROUND', 'citation': 'Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.'}, {'pmid': '33424089', 'type': 'BACKGROUND', 'citation': 'Mulita F, Parchas N, Solou K, Tchabashvili L, Gatomati F, Iliopoulos F, Maroulis I. Postoperative Pain Scores After Open Inguinal Hernia Repair: Comparison of Three Postoperative Analgesic Regimens. Med Arch. 2020 Oct;74(5):355-358. doi: 10.5455/medarh.2020.74.355-358.'}, {'type': 'BACKGROUND', 'citation': 'Burton, V. and P. A.J., Comparison of open and laparoscopic inguinal hernia repair. Mini-invasive Surgery, 2021. 5(26).'}, {'pmid': '24022443', 'type': 'BACKGROUND', 'citation': 'Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.'}, {'type': 'BACKGROUND', 'citation': 'Hammoud, M. and J. Gerken, Inguinal Hernia, in StatPearls. 2022: Treasure Island (FL).'}]}, 'descriptionModule': {'briefSummary': 'To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery', 'detailedDescription': 'Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh\n* ASA I or II\n* Ages 18 - 65\n\nExclusion Criteria:\n\n* Patient on chronic pain meds\n* Patient receiving analgesics 24hrs prior to surgery\n* Incarcerated or strangulated hernia or recurrent hernia\n* BMI \\>40\n* Allergic to medications being tested in this study'}, 'identificationModule': {'nctId': 'NCT06608056', 'briefTitle': 'Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Air Force (PAF) Hospital Islamabad'}, 'officialTitle': 'Comparing Opioid Vs Non Opioid Analgesics for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'SGR-2021-137-2499-2'}, 'secondaryIdInfos': [{'id': 'SGR-2021-137-2499-2', 'type': 'OTHER', 'domain': 'PAF Hospital ethical committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol', 'description': 'Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery', 'interventionNames': ['Drug: Pain management after surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Ketorolac', 'description': 'Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery', 'interventionNames': ['Drug: Pain management after surgery']}], 'interventions': [{'name': 'Pain management after surgery', 'type': 'DRUG', 'description': 'Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.', 'armGroupLabels': ['Ketorolac', 'Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Capital Territory', 'country': 'Pakistan', 'facility': 'Pakistan Air Force Hospital', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Air Force (PAF) Hospital Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-graduate resident, Principle Investigator, Department of General Surgery', 'investigatorFullName': 'Syed Moiz Ahmed', 'investigatorAffiliation': 'Pakistan Air Force (PAF) Hospital Islamabad'}}}}