The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair

NCT02766556 | Completed DMC

• 1 other identifier: 2013-112
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

arm 1

ACTIVE COMPARATOR

received ISB with 8mL of ropivacaine with 100 μg (1ml) of dexmedetomidine

Drug: dexmedetomidine; Procedure: ISB; Drug: Ropivacaine

arm 2

PLACEBO COMPARATOR

received ISB with 8mL of ropivacaine with 1ml of normal saline

Procedure: ISB; Drug: Ropivacaine

Interventions

dexmedetomidine DRUG

ISB with ropivacaine with dexmedetomidine or normal saline

Also known as: dexmedetomidine or normal saline

arm 1

ISB PROCEDURE

ISB with ropivacaine with dexmedetomidine or normal saline

Also known as: ISB for pain control

arm 1; arm 2

Ropivacaine DRUG

ISB with ropivacaine with dexmedetomidine or normal saline

Also known as: ISB using ropivacaine

arm 1; arm 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a definite rotator cuff tear that needed repair seen on preoperative magnetic resonance imaging
• acceptance of arthroscopic surgery including rotator cuff repair
• age more than 20 years,
• acceptance of preemptive regional block , PCA and blood sampling after 1 ,6, 12, 24, 48 hour postoperatively. .

You may not qualify if:

• they did not undergo arthroscopic rotator cuff repair
• they stopped PCA before 48 hours postoperatively because of associated side effects
• there was a history of a previous shoulder operation or fracture
• there was a concomitant neurologic disorder around the shoulder
• refusal of blood sampling.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Related Publications (16)

• 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: 22434159 RESULT

• Moote CA. The prevention of postoperative pain. Can J Anaesth. 1994 Jun;41(6):527-33. doi: 10.1007/BF03011550.

  PMID: 7915209 RESULT

• 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: 24317234 RESULT

• 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: 18719449 RESULT

• 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: 20814283 RESULT

• 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: 19858875 RESULT

• 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: 20889939 RESULT

• 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: 23161360 RESULT

• 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: 19935071 RESULT

• 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: 22923822 RESULT

• 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: 21666435 RESULT

• 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: 17195239 RESULT

• 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: 18165160 RESULT

• 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: 16508385 RESULT

• 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: 1559888 RESULT

• 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.

  PMID: 31773201 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Saline Solution; Analgesia; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jae Jun Lee, M.D.

  Department of Anesthesiology and Pain medicine, Chuncheon Sacred Heart Hospital, College of Medicine, Hallym University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 10, 2016
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share