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Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

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ClinicalTrials.gov Identifier: NCT03041506
Recruitment Status : Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Shoulder Dislocation Brachial Plexus Block Drug: Lidocaine Procedure: US guided ISCB Drug: Midazolam Drug: Ketamine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER
Estimated Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sedation

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
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.
Other Name: Midolam

Drug: Ketamine
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.
Other Name: Ketalar

Experimental: US guided ISCB

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

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.

Other Name: Xylocaine

Procedure: US guided ISCB

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.





Primary Outcome Measures :
  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 [ Time Frame: Up to 3 hours from shoulder dislocation reduction procedure ]

Secondary Outcome Measures :
  1. Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure [ Time Frame: Baseline ]
  2. Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision [ Time Frame: When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure ]
  3. Patient satisfaction from shoulder dislocation reduction procedure when subject is ready for discharge from the ER according to the physician decision [ Time Frame: When subject is ready for discharge from the ER according to the physician decision, up to 3 hours from shoulder dislocation reduction procedure ]
  4. Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure [ Time Frame: During shoulder dislocation reduction procedure ]
    1. Pneumothorax - clinical symptoms of dyspnea, hypoxemia, tachypnea + radiologic confirmation of pneumothorax
    2. Local anesthetic systemic toxicity - clinical symptoms range from tinnitus, metallic taste, seizures, loss of consciousness, cardiac arrhythmias, and cardiac arrest
    3. Intrathecal injection - local anesthetics penetrate into the subarachnoid space resulting in high spinal anesthesia
    4. Intravascular puncture - blood appear in the syringe
    5. Horner syndrome - ptosis, miosis and anhydrosis ipsilateral to the side of the ISCB
    6. Hoarseness - voice change
    7. Respiratory failure - phrenic nerve blockade with resultant diaphragmatic paresis in the ipsilateral side of the ISCB
    8. Neurologic injury - sensory or motor deficit after ISCB

  5. Complications related to sedation during shoulder dislocation reduction procedure [ Time Frame: During shoulder dislocation reduction procedure ]
    1. Respiratory complications - aspiration with signs of fluid or food regurgitation respiratory depression and upper airway obstruction
    2. Hemodynamic instability - cardiac arrhythmias and hypotension

  6. Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure [ Time Frame: During shoulder dislocation reduction procedure ]
    Failed ISCB - no loss of cold sensation over the blocked shoulder and no pain relief after ISCB

  7. Overall success rate for shoulder dislocation reduction procedure [ Time Frame: During shoulder dislocation reduction procedure ]
    Success full shoulder reduction - confirmed by an X ray study

  8. Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician [ Time Frame: During shoulder dislocation reduction procedure ]
    The orthopedic physician will be asked to describe his/her personal difficulty to perform the shoulder dislocation reduction procedure Severity score: 1-Easy; 2-Relatively easy; 3-Moderate; 4-Moderate to severe; 5-Severe

  9. Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure [ Time Frame: During shoulder dislocation reduction procedure ]
    Failed sedation - patient is uncooperative or in pain not allowing the orthopedic physician to perform reduction procedure

  10. Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER [ Time Frame: 24 hours after readiness for dismissal ]
  11. Readmission to the ER during 24 hours from readiness for dismissal from the ER [ Time Frame: During 24 hours from readiness for dismissal ]
    Any reason for patient readmission to the ER

  12. Limb daily activity level measured by "Quick DASH" score 72 hours from readiness for dismissal from the ER [ Time Frame: 72 hours from readiness for dismissal from the ER ]
    Quick DASH is a questionnaire that measure upper limb daily activity level



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041506


Contacts
Contact: Idit Matot, MD 97236974758 iditm@tlvmc.gov.il
Contact: Miri Davidovich 97236974758 mirid@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Idit Matot, MD Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center

Publications:

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03041506     History of Changes
Other Study ID Numbers: TASMC-16-IM-0221-CTIL
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data (IPD).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tel-Aviv Sourasky Medical Center:
Shoulder dislocation reduction
Ultrasound guided interscalene block (ISCB)
Sedation

Additional relevant MeSH terms:
Shoulder Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Ketamine
Midazolam
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents