Shoulder DislocationNCT03041506
Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction
A study testing Lidocaine, US guided ISCB and Midazolam in people with Shoulder Dislocation and Brachial Plexus Block, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation, Brachial Plexus Block
- What is being tested?
- Lidocaine, US guided ISCB and Midazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients (ASA SCORE I-III) without acute cardio-pulmonary decompensation, who arrive to the ER with shoulder dislocation for reduction maneuver.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER
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.
Read more
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.
Read the 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.
- Conditions
- Shoulder Dislocation, Brachial Plexus Block
- Keywords
- Shoulder dislocation reduction, Ultrasound guided interscalene block (ISCB), Sedation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
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 ISCBProcedure or surgery
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.
MidazolamDrug
Also called Midolam
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.
KetamineDrug
Also called Ketalar
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Lidocaine; Procedure: US guided ISCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 hours from shoulder dislocation reduction procedure
Secondary outcomes (12)
Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure
Measured: Baseline
Visual Analogue Score (VAS) when subject is ready for discharge from the ER according to the physician decision
Measured: 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
Measured: 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
- 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
Measured: During shoulder dislocation reduction procedure
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
Measured: During shoulder dislocation reduction procedure
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
Measured: During shoulder dislocation reduction procedure
Overall success rate for shoulder dislocation reduction procedure
Success full shoulder reduction - confirmed by an X ray study
Measured: During shoulder dislocation reduction procedure
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
Measured: During shoulder dislocation reduction procedure
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
Measured: During shoulder dislocation reduction procedure
Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER
Measured: 24 hours after readiness for dismissal
Readmission to the ER during 24 hours from readiness for dismissal from the ER
Any reason for patient readmission to the ER
Measured: During 24 hours from readiness for dismissal
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
Measured: 72 hours from readiness for dismissal from the ER
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start15 Feb 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Idit Matot, MD, Principal investigator, Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041506
- Sponsor's protocol ID
- TASMC-16-IM-0221-CTIL
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD).
Publications
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.
PubMed 12609642Orlinsky 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.
PubMed 11932085Matthews 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.
PubMed 7726351Burton 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.
PubMed 12399793Taylor 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.
PubMed 15635132Roback 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.
PubMed 15930401Blaivas 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.
PubMed 16635700Beaudoin 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.
PubMed 20006206Reid 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.
PubMed 19422409Abrahams 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.
PubMed 19174373Neal 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.
PubMed 26288034Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.
PubMed 12491553Singelyn 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.
PubMed 15271745Davis 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.
PubMed 19502031Liu 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.
PubMed 19535720
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER
- ClinicalTrials.gov ID
- NCT03041506
- Acronym / sponsor ID
- TASMC-16-IM-0221-CTIL
- Conditions
- Shoulder Dislocation, Brachial Plexus Block
- Keywords
- Shoulder dislocation reduction, Ultrasound guided interscalene block (ISCB), Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 15 Feb 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation | Active comparator | Drug: Midazolam, Drug: KetamineAnalgesia 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). |
| US guided ISCB | Experimental | Drug: Lidocaine, Procedure: US guided ISCBInfiltration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients (ASA SCORE I-III) without acute cardio-pulmonary decompensation, who arrive to the ER with shoulder dislocation for reduction maneuver.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: XylocaineInfiltration 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 | US guided ISCB |
| US guided ISCBInfiltration 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. | Procedure or surgery | US guided ISCB |
| MidazolamAlso: MidolamIV 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. | Drug | Sedation |
| KetamineAlso: KetalarIV administration up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds) for sedation and pain relief. | Drug | Sedation |
Primary outcome
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
12 secondary outcomes
Visual Analogue Score (VAS) before the shoulder dislocation reduction procedure
Time frame: Baseline
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
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
Side effect and complications related to US guided ISCB during shoulder dislocation reduction procedure
Time frame: During shoulder dislocation reduction procedure
Complications related to sedation during shoulder dislocation reduction procedure
Time frame: During shoulder dislocation reduction procedure
Failed US guided ISCB rate (preceded by sedation) during shoulder dislocation reduction procedure
Time frame: During shoulder dislocation reduction procedure
Overall success rate for shoulder dislocation reduction procedure
Time frame: During shoulder dislocation reduction procedure
Easiness of shoulder dislocation reduction procedure assessed by orthopedic physician
Time frame: During shoulder dislocation reduction procedure
Failed sedation rate (preceded by general anesthesia) during shoulder dislocation reduction procedure
Time frame: During shoulder dislocation reduction procedure
Visual Analogue Score (VAS) 24 hours after readiness for dismissal from ER
Time frame: 24 hours after readiness for dismissal
Readmission to the ER during 24 hours from readiness for dismissal from the ER
Time frame: During 24 hours from readiness for dismissal
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 12609642Perron 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.
- Background: PubMed 11932085Orlinsky 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.
- Background: PubMed 7726351Matthews 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.
- Background: PubMed 12399793Burton 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.
- Background: PubMed 15635132Taylor 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.
- Background: PubMed 15930401Roback 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.
- Background: PubMed 16635700Blaivas 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.
- Background: PubMed 20006206Beaudoin 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.
- Background: PubMed 19422409Reid 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.
- Background: PubMed 19174373Abrahams 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.
- Background: PubMed 26288034Neal 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.
- Background: PubMed 12491553Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit Matot, MD principal investigator
Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, US guided ISCB and Midazolam in people with Shoulder Dislocation and Brachial Plexus Block, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Idit Matot, MD (97236974758, iditm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041506, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.