Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

NCT03041506 | Unknown

• 1 other identifier: TASMC-16-IM-0221-CTIL
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Shoulder dislocation is the most common joint dislocation presented to the emergency room (ER) and reduction by medical team is always needed. Shoulder dislocation and reduction are often very painful and require some form of sedation, pain relief and muscle relaxation for reduction maneuvers. Several sedation protocols for reduction maneuver are described in the literature, and each institution is guided by its own protocol to optimize patient comfort and safety. At the Tel Aviv Medical Centre (TLVMC) ER sedation with ketamine and midazolam are the mainstay form of sedation for shoulder dislocation reduction. Sedation is not without risk, it is time consuming for the medical staff, and need personal supervision. Sedation under busy ER conditions can cause a burden to the medical team which can end up in treatment insufficiency and patient safety failure. Ultrasound (US) guided interscalene block (ISCB) for shoulder surgery was found to be an effective method for perioperative analgesia. However, there is limited data on performance of US guided ISCB for shoulder dislocation reduction and its comparison to other analgesic modalities Both techniques (block and sedation) for shoulder dislocation procedure are being performed for two years at the TLVMC, however no study was done to evaluate these two analgesic modalities. The current study compares sedation vs. US guided ISCB for the treatment of shoulder dislocation in the ER at the TLVMC. Study objective: Comparison of two common analgesic methods, Sedation vs. US guided ISCB, for shoulder dislocation reduction in our institution. Study design: This is a prospective, randomized, interventional, open-label study with two arms- Sedation group and US guided ISCB group. The sedation will be conducted by the orthopedic surgeon who is certified to perform sedation and the US guided ISCB will be conducted by a certified anesthesiologist. Primary outcome: Time frame measured from the beginning of reduction procedure until readiness for dismissal from the ER according to the physician decision. Secondary outcomes \[short list\]: Visual Analogue Score (VAS), patient satisfaction, complications, US guided ISCB and sedation failure rate, overall reduction success rate, readmission rate to the ER, daily activity level measured by Quick DASH (Disabilities of Arm, Shoulder and Hand) outcome measure.

Conditions

Shoulder Dislocation; Brachial Plexus Block

Keywords

Shoulder dislocation reduction; Ultrasound guided interscalene block (ISCB); Sedation

Outcome Measures

Primary Outcomes (1)

• Length of stay measured in minutes from the beginning of shoulder dislocation reduction procedure until the subject is ready for discharge from the ER according to the physician decision

  Up to 3 hours from shoulder dislocation reduction procedure

Secondary Outcomes (12)

• Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure

  Baseline

• Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision

  When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure

• Patient satisfaction from shoulder dislocation reduction procedure when subject is ready for discharge from the ER according to the physician decision

  When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure

• Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure

  During shoulder dislocation reduction procedure

• Complications related to sedation during shoulder dislocation reduction procedure

  During shoulder dislocation reduction procedure

Study Arms (2)

Sedation

ACTIVE COMPARATOR

Analgesia and sedation through IV medication for pain relief will be administered to the patient. Midazolam: up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 second). Ketamine: up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds).

Drug: Midazolam; Drug: Ketamine

US guided ISCB

EXPERIMENTAL

Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation. Lidocaine 2%: 15-20 ml.

Drug: Lidocaine; Procedure: US guided ISCB

Interventions

Lidocaine DRUG

Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation. Lidocaine 2%: 15 -20 ml.

Also known as: Xylocaine

US guided ISCB

US guided ISCB PROCEDURE

Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation. Lidocaine 2%: 15 -20 ml.

US guided ISCB

Midazolam DRUG

IV administration up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 seconds) for sedation and pain relief.

Also known as: Midolam

Sedation

Ketamine DRUG

IV administration up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds) for sedation and pain relief.

Also known as: Ketalar

Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients (ASA SCORE I-III) without acute cardio-pulmonary decompensation, who arrive to the ER with shoulder dislocation for reduction maneuver.

You may not qualify if:

• Unconscious patient
• Patient refusal/unable to give informed consent
• Patients with acute cardio-pulmonary decompensation
• Patients with known allergy to medications which will be included in the study
• Patients who suffer additional injuries and need to be hospitalized for further treatment
• Patients who received narcotic/sedative premedication before the procedure

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (16)

• Perron AD, Ingerski MS, Brady WJ, Erling BF, Ullman EA. Acute complications associated with shoulder dislocation at an academic Emergency Department. J Emerg Med. 2003 Feb;24(2):141-5. doi: 10.1016/s0736-4679(02)00717-5.

  PMID: 12609642 BACKGROUND

• Orlinsky M, Shon S, Chiang C, Chan L, Carter P. Comparative study of intra-articular lidocaine and intravenous meperidine/diazepam for shoulder dislocations. J Emerg Med. 2002 Apr;22(3):241-5. doi: 10.1016/s0736-4679(01)00475-9.

  PMID: 11932085 BACKGROUND

• Matthews DE, Roberts T. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study. Am J Sports Med. 1995 Jan-Feb;23(1):54-8. doi: 10.1177/036354659502300109.

  PMID: 7726351 BACKGROUND

• Burton JH, Bock AJ, Strout TD, Marcolini EG. Etomidate and midazolam for reduction of anterior shoulder dislocation: a randomized, controlled trial. Ann Emerg Med. 2002 Nov;40(5):496-504. doi: 10.1067/mem.2002.126607.

  PMID: 12399793 BACKGROUND

• Taylor DM, O'Brien D, Ritchie P, Pasco J, Cameron PA. Propofol versus midazolam/fentanyl for reduction of anterior shoulder dislocation. Acad Emerg Med. 2005 Jan;12(1):13-9. doi: 10.1197/j.aem.2004.08.039.

  PMID: 15635132 BACKGROUND

• Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009.

  PMID: 15930401 BACKGROUND

• Blaivas M, Lyon M. Ultrasound-guided interscalene block for shoulder dislocation reduction in the ED. Am J Emerg Med. 2006 May;24(3):293-6. doi: 10.1016/j.ajem.2005.10.004.

  PMID: 16635700 BACKGROUND

• Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.

  PMID: 20006206 BACKGROUND

• Reid N, Stella J, Ryan M, Ragg M. Use of ultrasound to facilitate accurate femoral nerve block in the emergency department. Emerg Med Australas. 2009 Apr;21(2):124-30. doi: 10.1111/j.1742-6723.2009.01163.x.

  PMID: 19422409 BACKGROUND

• Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.

  PMID: 19174373 BACKGROUND

• Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286.

  PMID: 26288034 BACKGROUND

• Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.

  PMID: 12491553 BACKGROUND

• Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.

  PMID: 15271745 BACKGROUND

• Davis JJ, Swenson JD, Greis PE, Burks RT, Tashjian RZ. Interscalene block for postoperative analgesia using only ultrasound guidance: the outcome in 200 patients. J Clin Anesth. 2009 Jun;21(4):272-7. doi: 10.1016/j.jclinane.2008.08.022. Epub 2009 Jun 6.

  PMID: 19502031 BACKGROUND

• Liu SS, Zayas VM, Gordon MA, Beathe JC, Maalouf DB, Paroli L, Liguori GA, Ortiz J, Buschiazzo V, Ngeow J, Shetty T, Ya Deau JT. A prospective, randomized, controlled trial comparing ultrasound versus nerve stimulator guidance for interscalene block for ambulatory shoulder surgery for postoperative neurological symptoms. Anesth Analg. 2009 Jul;109(1):265-71. doi: 10.1213/ane.0b013e3181a3272c.

  PMID: 19535720 BACKGROUND

• Blaivas M, Adhikari S, Lander L. A prospective comparison of procedural sedation and ultrasound-guided interscalene nerve block for shoulder reduction in the emergency department. Acad Emerg Med. 2011 Sep;18(9):922-7. doi: 10.1111/j.1553-2712.2011.01140.x. Epub 2011 Aug 30.

  PMID: 21883635 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Lidocaine; Midazolam; Ketamine

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Idit Matot, MD

  Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, MD

CONTACT

97236974758; iditm@tlvmc.gov.il

Miri Davidovich

CONTACT

97236974758; mirid@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: February 2, 2017
• Study Start: February 15, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share