Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-26 @ 6:08 AM
Study NCT ID:
NCT02666118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Efficacy of Nerve Blockades', 'timeFrame': '60 minutes', 'description': 'The primary outcome will be the worst pain score observed in the PACU using 0 (no pain) to 10 (worst pain) verbal Numerical Rating Scale (NRS) for pain by the study staff during the first post-operative hour.'}]}, 'conditionsModule': {'keywords': ['pain', 'pain management', 'shoulder repair', 'nerve blockade', 'regional anesthesia', 'pediatrics'], 'conditions': ['Pain', 'Shoulder Injury']}, 'referencesModule': {'references': [{'pmid': '21965352', 'type': 'BACKGROUND', 'citation': 'Katz J, Clarke H, Seltzer Z. Review article: Preventive analgesia: quo vadimus? Anesth Analg. 2011 Nov;113(5):1242-53. doi: 10.1213/ANE.0b013e31822c9a59. Epub 2011 Sep 30.'}, {'pmid': '21455081', 'type': 'BACKGROUND', 'citation': "Lavand'homme P. From preemptive to preventive analgesia: time to reconsider the role of perioperative peripheral nerve blocks? Reg Anesth Pain Med. 2011 Jan-Feb;36(1):4-6. doi: 10.1097/AAP.0b013e31820305b8. No abstract available."}, {'pmid': '20708419', 'type': 'BACKGROUND', 'citation': 'Misamore G, Webb B, McMurray S, Sallay P. A prospective analysis of interscalene brachial plexus blocks performed under general anesthesia. J Shoulder Elbow Surg. 2011 Mar;20(2):308-14. doi: 10.1016/j.jse.2010.04.043. Epub 2010 Aug 13.'}, {'pmid': '20048655', 'type': 'BACKGROUND', 'citation': 'Fredrickson MJ, Ball CM, Dalgleish AJ. Analgesic effectiveness of a continuous versus single-injection interscalene block for minor arthroscopic shoulder surgery. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):28-33. doi: 10.1097/AAP.0b013e3181c771bd.'}, {'type': 'BACKGROUND', 'citation': 'Hadzic A, New York School of Regional Anesthesia: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007'}, {'pmid': '14673442', 'type': 'BACKGROUND', 'citation': 'Angelo RL. Controversies in arthroscopic shoulder surgery: arthroscopic versus open bankart repair, thermal treatment of capsular tissue, acromioplasties--are they necessary? Arthroscopy. 2003 Dec;19 Suppl 1:224-8. doi: 10.1016/j.arthro.2003.10.005. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Nerve blocks, or pain medication injected next to the nerve while patients are asleep, are commonly used for pain management after shoulder surgery and are considered highly effective in decreasing post-operative pain. There are several different ways to give a nerve block. All are effective and safe. The purpose of this research is to determine if one of the available ways to give a nerve block is more effective than the others.', 'detailedDescription': 'Interscalene brachial plexus blockade is commonly performed to provide relief of postoperative pain following surgical shoulder repair. This has proven to be a reliable means of reducing the required doses of intraoperative and postoperative opiates and effectively delaying postoperative pain, as well as hastening patient discharge and increasing patient satisfaction. Neural blockade has traditionally been performed prior to surgery with the hope that preemptive analgesia will most effectively abate postoperative pain. Recently, however, it has been argued that sensitization to pain can be attributed to many factors, not solely the nociceptive battery associated with incision and subsequent intraoperative events. The duration of action and effectiveness of the treatment modality thus appear play a more important role than the actual timing of the treatment delivered. The safety and efficacy of performing interscalene brachial plexus blockade under general anesthesia has recently been reported as being not only safe, but perhaps more effective than when performed in an awake patient. We propose a randomized prospective evaluation of the analgesic efficacy comparing interscalene brachial plexus blockade performed prior to surgery with interscalene brachial plexus blockade performed following the completion of of surgery in healthy ASA I and II adolescent patients undergoing unilateral shoulder reconstruction on an outpatient basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is male or female;\n* The subject is of any racial and ethnic groups;\n* The subject is age 10 years to 21 years (inclusive);\n* The subject is scheduled for the following\n* Unilateral shoulder repair under general anesthesia on an out- patient basis, and not being performed in conjunction with any other surgical procedures;\n* Agreement of the surgeon for subject participation in study.\n* The subject or legally authorized representative has consented to an intra- scalene block for the procedure and the consent for the block has been obtained by an clinician (MD, DO, CRNA or APN) authorized to obtain consent who is independent of the study team\n* The subject is American Society of Anesthesiologists (ASA) patient classification I-II;\n* The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.\n\nExclusion Criteria:\n\n* Additional surgical procedures are being performed concurrently;\n* The subject is ASA classification \\> II;\n* The subject has pre-existing allergies to local anesthetics;\n* The subject receives sedation preoperatively;\n* The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;\n* The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study, including but not limited preexisting neuropathy."}, 'identificationModule': {'nctId': 'NCT02666118', 'briefTitle': 'Efficacy of Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Intervention', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Randomized Prospective Comparison of Analgesic Efficacy of Peripheral Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Shoulder Repair', 'orgStudyIdInfo': {'id': '2012-0486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preemptive Interscalene Block - Single Shot', 'interventionNames': ['Procedure: Preemptive Interscalene Block - Single Shot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Postoperative Interscalene Block - Single Shot', 'interventionNames': ['Procedure: Postoperative Interscalene Block- Single Shot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preemptive Interscalene Block - Catheter', 'interventionNames': ['Procedure: Preemptive Interscalene Block - Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Postoperative Interscalene Block - Catheter', 'interventionNames': ['Procedure: Postoperative Interscalene Block - Catheter']}], 'interventions': [{'name': 'Preemptive Interscalene Block - Single Shot', 'type': 'PROCEDURE', 'description': 'Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.', 'armGroupLabels': ['Preemptive Interscalene Block - Single Shot']}, {'name': 'Postoperative Interscalene Block- Single Shot', 'type': 'PROCEDURE', 'description': 'Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.', 'armGroupLabels': ['Postoperative Interscalene Block - Single Shot']}, {'name': 'Preemptive Interscalene Block - Catheter', 'type': 'PROCEDURE', 'description': 'Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.', 'armGroupLabels': ['Preemptive Interscalene Block - Catheter']}, {'name': 'Postoperative Interscalene Block - Catheter', 'type': 'PROCEDURE', 'description': 'Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.', 'armGroupLabels': ['Postoperative Interscalene Block - Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Marc Mecoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}