Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-27 @ 4:56 PM
Study NCT ID:
NCT04700592
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2021-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-30', 'studyFirstSubmitDate': '2021-01-02', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative neuropathic pain', 'timeFrame': 'three months of surgery', 'description': 'the DN4 questionnaire'}], 'secondaryOutcomes': [{'measure': 'acute pain postoperative', 'timeFrame': 'At twenty-four hour postoperative', 'description': 'the visual analogue scales (VAS) at rest and at motion'}, {'measure': 'Consumption of morphine', 'timeFrame': 'At 24 hour postoperative', 'description': 'measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post operative chronic pain', 'gabapentin', 'ketamin', 'Inguinal Hernia Repair'], 'conditions': ['Chronic Pain Following Surgical Procedure for Cancer']}, 'descriptionModule': {'briefSummary': 'Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.', 'detailedDescription': "the investigators includes patients aged at least 18 classified as ASA I and II. Patients with significant cardiovascular or central nervous system disease, as well as those with renal or liver failure and those who could not operate the PCA device were not eligible for our study.\n\nExclusion criteria were patients that had incidents during the surgery such as: an allergic reaction, local anesthetic systemic toxicity or a surgical incident.\n\nPatients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.\n\nUpon arrival in the operating room, patients were monitored using mean blood pressure, heart rate and peripheral oxygen saturation monitors.\n\nThe surgery was performed under spinal anesthesia. Each patient received 10 mg of hyperbaric bupivacaine mixed with 5 µ of sufentanil.\n\nImmediately after the intervention, the patients were transferred to the post anesthesia care unit (PACU) where analgesia was arranged through morphine titration.\n\nAfter the motor block is lifted, patients were transferred to surgery department where they were connected to a PCA device that provided 1 mg IV bolus injection of morphine at a lockout interval of 7 minutes and with a maximum four-hour limit of 0.5 mg/Kg.\n\nDuring the hospital stay, acute post-operative pain assessed through the visual analog scale (VAS) at rest and at motion, every 15 minutes in the PACU and then at H2, H6, H12 and H24 postoperative.\n\nThe morphine consumption was noted as well as its first demand. Sedation was assessed using the Ramsay score. The occurrence of adverse effects such as nausea and vomiting, dizziness, diarrhea, hallucination and pruritus was also noted.\n\nThe first night sleep quality was evaluated through the Spiegel score. After hospital discharge, patients were contacted at one month and three months. The incidence of post-operative neuropathic pain was detected by the DN4 questionnaire. The effect the pain had on their daily activities was also judged.\n\nStatistical analysis:\n\nAccording to available data (30% occurrence of post-operative chronic pain after inguinal hernia repair (2)), to decrease by 25% this number with a power of 80%, 28 patients were needed in each group.\n\nStatistical analysis was performed with SPSS in its 20 version. Results were expressed as mean, standard variation or median. χ2 test, fisher's exact test and Mann-Whitney test were performed. A P value of \\< 0.05 was considered as statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I and II\n* Inguinal Hernia Repair in non emergent conditions\n\nExclusion Criteria:\n\n* Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device'}, 'identificationModule': {'nctId': 'NCT04700592', 'briefTitle': 'A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'UTEM GABA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin group', 'description': 'group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery', 'interventionNames': ['Other: Gabapentin versus Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'ketamine group', 'description': 'group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision', 'interventionNames': ['Other: Gabapentin versus Ketamine']}], 'interventions': [{'name': 'Gabapentin versus Ketamine', 'type': 'OTHER', 'otherNames': ['acute and Chronic Pain'], 'description': 'A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain', 'armGroupLabels': ['Gabapentin group', 'ketamine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Nabeul', 'country': 'Tunisia', 'facility': 'Mechaal Benali', 'geoPoint': {'lat': 36.45606, 'lon': 10.73763}}], 'overallOfficials': [{'name': 'mechaal benali, PROFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university manar Tunis tunisia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mechaal Benali', 'investigatorAffiliation': 'University Tunis El Manar'}}}}