the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block

Phase 4

Completed

Conditions: Opioid Use, Unspecified

Interventions: Drug: Ropivacaine
Drug: Dexmedetomidine
Drug: Dexamethasone

Registration Number: NCT02653144

Lead Sponsor: Montefiore Medical Center

Brief Summary: The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.

Detailed Description: Currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. In general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. However, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. In addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally.

Dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. As a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. Although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. When administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. The safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. Nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

ASA 3 and 4
Pre-existing pain disorder
Regular consumption of chronic pain medication
Anatomical abnormalities of upper extremity
Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
Known allergy to dexmedetomidine
Coagulopathy
Uncontrolled Diabetes

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine and ropivacaine group	Ropivacaine	In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
dexmedetomidine and ropivacaine group	Dexmedetomidine	In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
ropivacaine only group	Ropivacaine	In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
dexamethasone and ropivacaine group	Ropivacaine	In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
dexamethasone and ropivacaine group	Dexamethasone	In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone

Primary Outcome Measures

Name	Time	Method
Opioid Requirements (Morphine Equivalents)	24 hours	How much opioid did patient ask for within 24 hours post op

Secondary Outcome Measures

Name	Time	Method
Opioid Requirements (Morphine Equivalents)	48 hours	How much opioid did patient ask for within 48 hours post op
Time to Discharge From PACU to First Opioid Consumption	24-48 hours after surgery	How long after surgery does patient take to ask for opioid to manage pain
Return of Motor and Sensory Function	24-48 hours after surgery	Between 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned.