Clinical Trial: Interscalene Nerve Block vs. Sedation for Shoulder Dislocation Reduction
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: US Guided Interscalene Block Compared With Sedation for Shoulder Dislocation Reduction in the ER
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:
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 atmo
Sponsor: Tel-Aviv Sourasky Medical Center
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During shoulder dislocation reduction procedure ]Success full shoulder reduction - confirmed by an X ray study
- 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
- 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
- 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 ]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 [ Time Frame: 72 hours from readiness for dismissal from the ER ]Quick DASH is a questionnaire that measure upper limb daily activity level
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: January 22, 2017
Date Started: February 15, 2017
Date Completion: December 31, 2018
Last Updated: February 5, 2017
Last Verified: February 2017
