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Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

Primary Purpose

Shoulder Dislocation, Brachial Plexus Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
US guided ISCB
Midazolam
Ketamine
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Shoulder dislocation reduction, Ultrasound guided interscalene block (ISCB), Sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Sedation

    US guided ISCB

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure
    Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision
    Patient satisfaction from shoulder dislocation reduction procedure when subject is ready for discharge from the ER according to the physician decision
    Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure
    Pneumothorax - clinical symptoms of dyspnea, hypoxemia, tachypnea + radiologic confirmation of pneumothorax Local anesthetic systemic toxicity - clinical symptoms range from tinnitus, metallic taste, seizures, loss of consciousness, cardiac arrhythmias, and cardiac arrest Intrathecal injection - local anesthetics penetrate into the subarachnoid space resulting in high spinal anesthesia Intravascular puncture - blood appear in the syringe Horner syndrome - ptosis, miosis and anhydrosis ipsilateral to the side of the ISCB Hoarseness - voice change Respiratory failure - phrenic nerve blockade with resultant diaphragmatic paresis in the ipsilateral side of the ISCB Neurologic injury - sensory or motor deficit after ISCB
    Complications related to sedation during shoulder dislocation reduction procedure
    Respiratory complications - aspiration with signs of fluid or food regurgitation respiratory depression and upper airway obstruction Hemodynamic instability - cardiac arrhythmias and hypotension
    Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure
    Failed ISCB - no loss of cold sensation over the blocked shoulder and no pain relief after ISCB
    Overall success rate for shoulder dislocation reduction procedure
    Success full shoulder reduction - confirmed by an X ray study
    Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician
    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
    Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure
    Failed sedation - patient is uncooperative or in pain not allowing the orthopedic physician to perform reduction procedure
    Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER
    Readmission to the ER during 24 hours from readiness for dismissal from the ER
    Any reason for patient readmission to the ER
    Limb daily activity level measured by "Quick DASH" score 72 hours from readiness for dismissal from the ER
    Quick DASH is a questionnaire that measure upper limb daily activity level

    Full Information

    First Posted
    January 22, 2017
    Last Updated
    February 5, 2017
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041506
    Brief Title
    Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction
    Official Title
    US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2017 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Shoulder dislocation is the most prevalent dislocation with a frequency of 0.5%-1.7% among the population, which requires reduction by medical staff in the emergency room (ER). Reduction procedure is often painful and require some level of sedation, analgesia, and muscle relaxation for its completeness. 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. The literature describes multiple sedative agents such as Propofol, Etomidate, Midazolam, Fentanyl, etc. In the emergency department (ED) at Tel Aviv Medical Center (TLVMC), the sedation protocol contains Midazolam and Ketamine as the main sedative and analgesic agents. Sedation is not without a risk. Known complications are respiratory depression, aspiration, and hemodynamic instability. These complications seem to be more prevalent in patients with decreased cardio-respiratory reserves, such as elderly, morbid obese, obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) patients. In addition, sedation requires resources such a facility occupied with equipment for monitoring vitals, oxygen supply source, capnography and human resources including medical staff certified to provide sedation and handle any possible complication and nursing staff supervising the patient throughout the procedure from admission until release home from the ER. The ED at the TLVMC is very active and busy throughout the day. Sedation under such condition create a real challenge for the medical team. This is translated into shortage in manpower and equipment availability and time needed to care for each patient. Such an atmosphere create huge burden on the medical team which can end up in treatment insufficiency and patient safety failure. Recently, several new publications were published regarding the implementation of peripheral nerve block (PNB) under US guidance for analgesia and painful orthopedic procedure in the ER. Implementation of PNB for pain management in orthopedic procedures in the ER might constitute theoretical advantages over sedation. Interscalene block (ISCB) is a very effective tool being used during shoulder surgery. However, there is limited data on performance of US guided ISCB for shoulder dislocation reduction and it's comparison with other analgesic modalities.Only one study to date compared sedation vs. US guided ISCB for shoulder dislocation reduction procedure in the ER. This study showed that patients who received ISCB had a shorter length of stay in the ER and required less supervision and medical intervention from the medical team. Both US guided ISCB and sedation for shoulder dislocation procedure are being performed for a while at TLVMC. However no study was done to evaluate them and determine if one of the analgesic modality have any advantages over the other. Objectives: Comparison of two common analgesic methods, US guided ISCB vs.sedation, for shoulder dislocation reduction in the ER at the TLVMC. Methods and Materials Study Design: This is a prospective, randomized, interventional non-blinded study with two arms- US guided ISCB group and Sedation group. The sedation will be conducted by an orthopedic physician certified to perform sedation and the US guided ISCB will be conducted by an anesthesiologist who has at least one year of experience preforming regional anesthesia using US guidance. Sample Size: The study will include 70 subjects - 35 in each group. In order to compensate for dropouts we will aim for recruitment of 90 subjects. Statistical Analysis: Quantitative data with normal distribution will be evaluated using t-test for independent samples. In case the assumptions for parametric test will not hold true, quantitative data will be evaluated using an a- parametric Mann-Whitney test. Quantitative variables will be presented as mean and standard deviation. Dichotomous data will be evaluated using chi-square test. Fischer exact test will be used when more than 20% of the expected observations were less than 5 or any expected observation was less than 2. Categorical data will be presented as a number of cases and percent. Multivariate logistic regression analysis will be used for the primary outcome in order to determine independent risk factors. The data included in the multivariate logistic regression model will have a clinical significance according to the investigator clinical judgment and data found to have a Pv<0.1 in the univariate analysis. A Pv of 0.05 will be considered significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Dislocation, Brachial Plexus Block
    Keywords
    Shoulder dislocation reduction, Ultrasound guided interscalene block (ISCB), Sedation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sedation
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    US guided ISCB
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Other Intervention Name(s)
    Xylocaine
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    US guided ISCB
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Other Intervention Name(s)
    Midolam
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketalar
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure
    Time Frame
    Baseline
    Title
    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
    Title
    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
    Title
    Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure
    Description
    Pneumothorax - clinical symptoms of dyspnea, hypoxemia, tachypnea + radiologic confirmation of pneumothorax Local anesthetic systemic toxicity - clinical symptoms range from tinnitus, metallic taste, seizures, loss of consciousness, cardiac arrhythmias, and cardiac arrest Intrathecal injection - local anesthetics penetrate into the subarachnoid space resulting in high spinal anesthesia Intravascular puncture - blood appear in the syringe Horner syndrome - ptosis, miosis and anhydrosis ipsilateral to the side of the ISCB Hoarseness - voice change Respiratory failure - phrenic nerve blockade with resultant diaphragmatic paresis in the ipsilateral side of the ISCB Neurologic injury - sensory or motor deficit after ISCB
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Complications related to sedation during shoulder dislocation reduction procedure
    Description
    Respiratory complications - aspiration with signs of fluid or food regurgitation respiratory depression and upper airway obstruction Hemodynamic instability - cardiac arrhythmias and hypotension
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure
    Description
    Failed ISCB - no loss of cold sensation over the blocked shoulder and no pain relief after ISCB
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Overall success rate for shoulder dislocation reduction procedure
    Description
    Success full shoulder reduction - confirmed by an X ray study
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician
    Description
    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
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure
    Description
    Failed sedation - patient is uncooperative or in pain not allowing the orthopedic physician to perform reduction procedure
    Time Frame
    During shoulder dislocation reduction procedure
    Title
    Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER
    Time Frame
    24 hours after readiness for dismissal
    Title
    Readmission to the ER during 24 hours from readiness for dismissal from the ER
    Description
    Any reason for patient readmission to the ER
    Time Frame
    During 24 hours from readiness for dismissal
    Title
    Limb daily activity level measured by "Quick DASH" score 72 hours from readiness for dismissal from the ER
    Description
    Quick DASH is a questionnaire that measure upper limb daily activity level
    Time Frame
    72 hours from readiness for dismissal from the ER

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Idit Matot, MD
    Phone
    97236974758
    Email
    iditm@tlvmc.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miri Davidovich
    Phone
    97236974758
    Email
    mirid@tlvmc.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Idit Matot, MD
    Organizational Affiliation
    Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan to share individual participant data (IPD).
    Citations:
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    Citation
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    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.
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    Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

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