The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery

Shoulder Pain Clinical Trial

— DEX  

Official title:

The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225054
• Other study ID #: DEX-2013
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2014
• Last updated: November 2, 2017
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2017
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.

Description:

Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.

Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.

The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• unilateral surgical shoulder procedures under general anesthetic

• English speaking patients

• ASA I-III patients

• BMI <38 kg/m2

Exclusion Criteria:

• proximal clavicular surgery

• preexisting neurological deficits or peripheral neuropathy

• known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias

• known cerebrovascular disease

• baseline heart rate <60 beats per minute or baseline systolic blood pressure <100 mm Hg

• medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment

• severe bronchopulmonary disease

• local infection

• contra-indication to regional anesthesia (bleeding, coagulopathy)

• chronic pain disorders

• current use of over 30mg oxycodone or equivalent per day

• contraindication to a component of multimodal analgesia

• allergy to local anesthetics or dexmedetomidine

• history of significant psychiatric conditions that may affect patient assessment

• pregnancy

• inability to provide consent

Related Conditions & MeSH terms

• Nerve Pain
• Neuralgia
• Shoulder Pain

Intervention

Drug:
• Dexmedetomidine
0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction
• Ropivacaine
15 ml 0.5%
• Normal Saline
1 mL 0.9%

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of interscalene nerve block.		Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
Primary	Opioid consumption		Cumulative opioid consumption at 24 hours postoperatively
Secondary	Opioid Consumption	The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.	Total use of opioids from the period of intra-operative to 2 weeks post-operative