Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 2:46 PM
Study NCT ID:
NCT02766556
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of five biomarkers (IL-6 in pg/ml, cortisol in ng/ml, IL-8 in pg/ml, IL-1beta in pg/ml, substance p in pg/ml) level due to pain after shoulder surgery.', 'timeFrame': 'change from preoperation(baseline) IL-6, cortisol, IL-8, IL-1beta, and substance p level 1, 6, 12, 24, 48 hours after surgery due to postoperative pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '22434159', 'type': 'RESULT', 'citation': 'Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21.'}, {'pmid': '7915209', 'type': 'RESULT', 'citation': 'Moote CA. The prevention of postoperative pain. Can J Anaesth. 1994 Jun;41(6):527-33. doi: 10.1007/BF03011550.'}, {'pmid': '24317234', 'type': 'RESULT', 'citation': 'Fritsch G, Danninger T, Allerberger K, Tsodikov A, Felder TK, Kapeller M, Gerner P, Brummett CM. Dexmedetomidine added to ropivacaine extends the duration of interscalene brachial plexus blocks for elective shoulder surgery when compared with ropivacaine alone: a single-center, prospective, triple-blind, randomized controlled trial. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):37-47. doi: 10.1097/AAP.0000000000000033.'}, {'pmid': '18719449', 'type': 'RESULT', 'citation': 'Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.'}, {'pmid': '20814283', 'type': 'RESULT', 'citation': 'Brummett CM, Amodeo FS, Janda AM, Padda AK, Lydic R. Perineural dexmedetomidine provides an increased duration of analgesia to a thermal stimulus when compared with a systemic control in a rat sciatic nerve block. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):427-31. doi: 10.1097/AAP.0b013e3181ef4cf0.'}, {'pmid': '19858875', 'type': 'RESULT', 'citation': 'Brummett CM, Padda AK, Amodeo FS, Welch KB, Lydic R. Perineural dexmedetomidine added to ropivacaine causes a dose-dependent increase in the duration of thermal antinociception in sciatic nerve block in rat. Anesthesiology. 2009 Nov;111(5):1111-9. doi: 10.1097/ALN.0b013e3181bbcc26.'}, {'pmid': '20889939', 'type': 'RESULT', 'citation': 'Esmaoglu A, Yegenoglu F, Akin A, Turk CY. Dexmedetomidine added to levobupivacaine prolongs axillary brachial plexus block. Anesth Analg. 2010 Dec;111(6):1548-51. doi: 10.1213/ANE.0b013e3181fa3095. Epub 2010 Oct 1.'}, {'pmid': '23161360', 'type': 'RESULT', 'citation': 'Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.'}, {'pmid': '19935071', 'type': 'RESULT', 'citation': 'Obayah GM, Refaie A, Aboushanab O, Ibraheem N, Abdelazees M. Addition of dexmedetomidine to bupivacaine for greater palatine nerve block prolongs postoperative analgesia after cleft palate repair. Eur J Anaesthesiol. 2010 Mar;27(3):280-4. doi: 10.1097/EJA.0b013e3283347c15.'}, {'pmid': '22923822', 'type': 'RESULT', 'citation': 'Swami SS, Keniya VM, Ladi SD, Rao R. Comparison of dexmedetomidine and clonidine (alpha2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: A randomised double-blind prospective study. Indian J Anaesth. 2012 May;56(3):243-9. doi: 10.4103/0019-5049.98767.'}, {'pmid': '21666435', 'type': 'RESULT', 'citation': 'Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.'}, {'pmid': '17195239', 'type': 'RESULT', 'citation': 'Brenn D, Richter F, Schaible HG. Sensitization of unmyelinated sensory fibers of the joint nerve to mechanical stimuli by interleukin-6 in the rat: an inflammatory mechanism of joint pain. Arthritis Rheum. 2007 Jan;56(1):351-9. doi: 10.1002/art.22282.'}, {'pmid': '18165160', 'type': 'RESULT', 'citation': 'Buenaver LF, Edwards RR, Smith MT, Gramling SE, Haythornthwaite JA. Catastrophizing and pain-coping in young adults: associations with depressive symptoms and headache pain. J Pain. 2008 Apr;9(4):311-9. doi: 10.1016/j.jpain.2007.11.005. Epub 2007 Dec 31.'}, {'pmid': '16508385', 'type': 'RESULT', 'citation': 'Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C, Negrescu C, Moric M, Caicedo MS, Tuman KJ. Upregulation of prostaglandin E2 and interleukins in the central nervous system and peripheral tissue during and after surgery in humans. Anesthesiology. 2006 Mar;104(3):403-10. doi: 10.1097/00000542-200603000-00005.'}, {'pmid': '1559888', 'type': 'RESULT', 'citation': 'Frank LA, Kunkle GA, Beale KM. Comparison of serum cortisol concentration before and after intradermal testing in sedated and nonsedated dogs. J Am Vet Med Assoc. 1992 Feb 15;200(4):507-10.'}, {'pmid': '31773201', 'type': 'DERIVED', 'citation': 'Hwang JT, Jang JS, Lee JJ, Song DK, Lee HN, Kim DY, Lee SS, Hwang SM, Kim YB, Lee S. Dexmedetomidine combined with interscalene brachial plexus block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2020 Jul;28(7):2343-2353. doi: 10.1007/s00167-019-05799-3. Epub 2019 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The present study was designed to test the hypothesis that dexmedetomidine added to ropivacaine for interscalene brachial plexus blocks for elective shoulder surgery would enhance the duration and effect of analgesia when compared with ropivacaine alone, and their influence on serum IL-6, cortisol, IL-1beta, IL-8, and substance p.', 'detailedDescription': 'Background The incidence of severe postoperative pain after shoulder surgery is 30% to 70%.The postoperative pain should be relieved for early rehabilitation and recovery. Patient-controlled analgesia (PCA) with opiate therapy may control some of the postoperative pain, but it has several side effects such as nausea, vomiting, and dizziness, which can prevent early discharge. Conversely, there are several regional blocks to control postoperative pain. Interscalene brachial plexus block (ISB) is known as one of the most effective regional blocks for shoulder surgery, but it has relatively short duration of effect.\n\nDexmedetomidine (DEX), a selective agonist of α2-adrenergic receptors, can be an effective adjuvant to local anesthetics for peripheral nerve block. Preclinical and clinical studies have described prolonged duration of analgesia when dexmedetomidine was added to bupivacaine, levobupivacaine, or ropivacaine for peripheral perineural blocks.\n\nPro-inflammatory cytokines, such as interleukin-6 (IL-6), shows a high association with acute pain because they sensitize the nervous system. IL-6 levels in the plasma are detectable 60 minutes after injury, peaking at 4-6 hours, and are proportional to tissue injury.\n\nIncreased plasma cortisol concentrations can be detected within 15 minutes following exposure to a stressor. And several biomarkers related to pain have been studying.\n\nMethod 50 patients with rotator cuff tears who had undergone arthroscopic rotator cuff repairs were enrolled in this study. Rotator cuff tears were diagnosed by preoperative magnetic resonance imaging, and the size of the rotator cuff was confirmed at the time of arthroscopic operation. Indication for surgery was a symptomatic full-thickness rotator cuff tear or a partial thickness rotator cuff tear of more than 50% thickness in case of failed conservative therapy. Twenty-five patients were randomly allocated to group 1 and received both ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine . The other 25 patients were allocated to group 2 and received ISB with 8mL of ropivacaine with 1ml of normal saline.\n\nPower analysis indicated that a total sample size of 46 patients (23 patients in each cohort) would provide a statistical power of 99% with a 2-sided a level of 0.05 to detect significant differences in the visual analog scale (VAS) score at 6 hours postoperatively, assuming an effect size of 0.88 (mean difference, 2.46, standard deviation, 2.8). This was based on the mean and standard deviation of the VAS at 6 hours postoperatively observed in a pilot study of 20 patients.\n\nDouble-blinded randomization was performed as follows. The remaining 50 patients were randomly assigned to 1 of 2 groups depending on the additional dexmedetomidine. Randomization was performed with a computerized random-sequence generator by an independent nurse who prepared a syringe for added dexmedetomidine or saline according to the assignment. The patients and all the medical staff who participated in the operation were blinded of the assignment.\n\nVAS pain score, IL-6, cortisol, IL-1beta, IL-8, and substance p, height, and weight were checked preoperatively. All ISB were performed preemptively under ultrasonographic guidance. After sterile preparation and draping of the injection area, the structures of the brachial plexus were identified using ultrasound (Sonosite M-Turbo 13 mHz linear probe; Sonosite Corp, Bothell, Washington). Injections were performed using an out-of-plane technique using a plexus needle (Plexus Nano Line Uniplex, 22 gauge, 50 mm; Pajunk Corp, Geisingen, Germany). Nerve stimulation was not conducted.\n\nPCA was set at a fixed dose (fentanyl, 0.05 mg/kg loading dose and 0.03 mg/min/kg continuous dose) to remove the effect of a variable amount of PCA. VAS pain score, IL-6, cortisol, IL-1beta, IL-8, and substance p, were checked 1, 6, 12, 24, and 48 hours postoperatively. VAS pain score was selected from 0 to 10, with 0 being no pain and 10 being the most severe pain that the patient had ever experienced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a definite rotator cuff tear that needed repair seen on preoperative magnetic resonance imaging\n2. acceptance of arthroscopic surgery including rotator cuff repair\n3. age more than 20 years,\n4. acceptance of preemptive regional block , PCA and blood sampling after 1 ,6, 12, 24, 48 hour postoperatively. .\n\nExclusion Criteria:\n\n1. they did not undergo arthroscopic rotator cuff repair\n2. they stopped PCA before 48 hours postoperatively because of associated side effects\n3. there was a history of a previous shoulder operation or fracture\n4. there was a concomitant neurologic disorder around the shoulder\n5. refusal of blood sampling.'}, 'identificationModule': {'nctId': 'NCT02766556', 'briefTitle': 'The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Cortisol and IL-6 After Rotator Cuff Repair: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '2013-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'arm 1', 'description': 'received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine', 'interventionNames': ['Drug: dexmedetomidine', 'Procedure: ISB', 'Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'arm 2', 'description': 'received ISB with 8mL of ropivacaine with 1ml of normal saline', 'interventionNames': ['Procedure: ISB', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['dexmedetomidine or normal saline'], 'description': 'ISB with ropivacaine with dexmedetomidine or normal saline', 'armGroupLabels': ['arm 1']}, {'name': 'ISB', 'type': 'PROCEDURE', 'otherNames': ['ISB for pain control'], 'description': 'ISB with ropivacaine with dexmedetomidine or normal saline', 'armGroupLabels': ['arm 1', 'arm 2']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['ISB using ropivacaine'], 'description': 'ISB with ropivacaine with dexmedetomidine or normal saline', 'armGroupLabels': ['arm 1', 'arm 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jae Jun Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital, College of Medicine, Hallym University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jae Jun Lee', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}