Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction

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

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center

  lead OTHER_GOV

Principal Investigators

• Idit Matot, MD · Chair, Division of Anesthesiology & Critical Care & Pain Tel-Aviv Sourasky Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-15

Primary Completion

2017-12-31

Completion

2018-12-31