Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT06909851
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Pain Relief After Arthroscopic Knee Surgery: Adductor Canal Block and Genicular Nerve Block
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who are admitted to the orthopedic and traumatology clinic and are scheduled for arthroscopic knee surgery will be informed and monitored prior to the operation under spinal anesthesia. Preoperatively, either Adductor Canal Block (ACB) (Group A) or Genicular Nerve Block (GNB) (Group B) will be applied. Randomization will be performed using a computer-based method (http://www.randomizer.org) with a 1:1 allocation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness on Pain Scores (NRS)', 'timeFrame': 'Postoperative 24 hours', 'description': 'Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at Baseline 0, postoperative 1st, 2nd, 4th, 6th, 12th, and 24th hours after applying a preoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").'}], 'secondaryOutcomes': [{'measure': 'Amount of rescue analgesia administration', 'timeFrame': 'Postoperative 24 hours.', 'description': 'After the surgery all patients will be given 4 times a day Paracetamol 1 gram. Patients who still have pain (NRS 4 or higher) will be given Tramadol 1 mg/kg (maximum 400 mg Tramadol daily). Postoperative 24 hours the amount of the rescue analgesic (Tramadol) will be noted.'}, {'measure': 'Postoperative Blood pressure', 'timeFrame': 'Postoperative 24 hours', 'description': "Participants' blood pressure (mm/hg) will be monitored for 24 hours (Post op 1st, 2nd, 4th, 6th, 12th and 24th hours) postoperatively."}, {'measure': 'Length of hospital stay', 'timeFrame': 'Postoperative 14 days', 'description': 'Length of hospital stay will be noted.'}, {'measure': 'First Time Of Mobilisation/Exercise', 'timeFrame': 'Postoperative 24 hours', 'description': 'First time of mobilisation/exercise will be noted.'}, {'measure': 'The Time of Rescue Analgesic', 'timeFrame': 'Postoperative 24 hours', 'description': 'After the surgery all patients will be given 4 times a day Paracetamol 1 gram. Patients who still have pain (NRS 4 or higher) will be given Tramadol 1 mg/kg (maximum 400 mg Tramadol daily). Postoperative 24 hours the time of the rescue analgesic usage (Tramadol) will be noted.'}, {'measure': 'Postoperative heart rate', 'timeFrame': 'Postoperative 24 hours', 'description': "Participants' heart rate (bpm) will be monitored for 24 hours (Post op 1st, 2nd, 4th, 6th, 12th and 24th hours) postoperatively."}, {'measure': 'Postoperative oxygen saturation levels', 'timeFrame': 'Postoperative 24 hours', 'description': "Participants' oxygen saturation levels (spO2 %) will be monitored for 24 hours (Post op 1st, 2nd, 4th, 6th, 12th and 24th hours) postoperatively."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genicular Nerve Block', 'Arthroscopic Knee Surgery', 'Adductor Canal Block', 'Postoperative Analgesia'], 'conditions': ['Opioid Use', 'Pain Postoperative', 'Arthroscopic Knee Surgeries']}, 'referencesModule': {'references': [{'pmid': '27871547', 'type': 'BACKGROUND', 'citation': 'Vora MU, Nicholas TA, Kassel CA, Grant SA. Adductor canal block for knee surgical procedures: review article. J Clin Anesth. 2016 Dec;35:295-303. doi: 10.1016/j.jclinane.2016.08.021. Epub 2016 Oct 11.'}, {'pmid': '37140579', 'type': 'BACKGROUND', 'citation': 'Tamam A, Guven Kose S, Kose HC, Akkaya OT. Comparison of the Effectiveness of Ultrasound-Guided Proximal, Mid, or Distal Adductor Canal Block after Knee Arthroscopy. Turk J Anaesthesiol Reanim. 2023 Apr;51(2):135-142. doi: 10.5152/TJAR.2023.22225.'}]}, 'descriptionModule': {'briefSummary': "This prospective randomized study aims to compare the analgesic efficacy of Adductor Canal Block (ACB) and Genicular Nerve Block (GNB) groups to relieve postoperative pain in participants between ages of 18-72 undergoing arthroscopic knee surgery under spinal anesthesia. The main question it aims to answer is:\n\nTo demonstrate whether Adductor Canal Block or Genicular Nerve Block is more effective in postoperative analgesia in patients undergoing arthroscopic knee surgery based on pain scores, opioid consumption and patient satisfaction.\n\nArthroscopic knee surgeries cause severe pain especially with movement in the post-operative period. After surgery, the movements of the participants are severely restricted because of pain, which increases the possibility of complications and postpones post-operative knee exercises. In this study, the participants' pain status, VAS score, opioid consumption and patient satisfaction will be measured with a simple scoring system for 24 hours at predetermined time points and then compared. Both types of blocks have pain-relieving effects. This study will only investigate which one is more effective in reducing pain, and there will be no deficiency in relieving the pain of the participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary willingness to participate in the study.\n* Patients undergoing arthroscopic knee surgery (meniscus, ACL, arthroscopic intervention etc).\n* ASA I-II-III classification.\n* Aged between 18-72 years.\n* No contraindications for regional anesthesia, and deemed suitable for regional anesthesia by the anesthesiologist.\n* Undergoing surgery under spinal anesthesia.\n* Fully oriented and able to cooperate.\n\nExclusion Criteria:\n\n* Undergoing surgery under general anesthesia.\n* Chronic analgesic use.\n* Presence of an active infection at the procedure site.\n* Outside the appropriate age range.\n* Inability to comply with postoperative pain/NRS follow-ups.\n* ASA IV-V classification.\n* Non-voluntary patients.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06909851', 'briefTitle': 'Comparison of Pain Relief After Arthroscopic Knee Surgery: Adductor Canal Block and Genicular Nerve Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Adductor Canal Block and Genicular Nerve Block on Postoperative Pain and Analgesic Use in Arthroscopic Knee Surgeries', 'orgStudyIdInfo': {'id': 'BSH-ANES-SA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACB Group', 'description': 'Participants undergoing arthroscopic knee surgery under spinal anestesia receiving pre operative Adductor Canal Block (ACB)', 'interventionNames': ['Procedure: Adductor Canal Block (ACB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Genicular Nerve Block', 'description': 'Participants undergoing arthroscopic knee surgery under spinal anestesia receiving pre operative Genicular Nerve Block (GNB)', 'interventionNames': ['Procedure: Genicular Nerve Block (GNB)']}], 'interventions': [{'name': 'Adductor Canal Block (ACB)', 'type': 'PROCEDURE', 'description': 'Evaluation of postoperative analgesic effectiveness of ACB block in participants undergoing arthroscopic knee surgery under spinal anesthesia.', 'armGroupLabels': ['ACB Group']}, {'name': 'Genicular Nerve Block (GNB)', 'type': 'PROCEDURE', 'description': 'Evaluation of postoperative analgesic effectiveness of GNB block in participants undergoing arthroscopic knee surgery under spinal anesthesia.', 'armGroupLabels': ['Genicular Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SİNAN ANAŞ', 'role': 'CONTACT', 'email': 'tharkunbalrogs@gmail.com', 'phone': '+905314220762'}, {'name': 'MUZAFFER GENCER', 'role': 'CONTACT', 'email': 'dr.m.gencer07@gmail.com', 'phone': '+905059436459'}, {'name': 'MUZAFFER GENCER', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'SİNAN ANAŞ', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ABDURRAHMAN ENGİN BAYDEMİR', 'role': 'SUB_INVESTIGATOR'}, {'name': 'FUNDA GÜMÜŞ ÖZCAN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Başakşehir Çam & Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'MUZAFFER GENCER', 'role': 'CONTACT', 'email': 'dr.m.gencer07@gmail.com', 'phone': '+905059436459'}, {'name': 'SİNAN ANAŞ', 'role': 'CONTACT', 'email': 'tharkunbalrogs@gmail.com', 'phone': '+905314220762'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Muzaffer GENCER', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}