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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Opioid Use, Unspecified

Treatments: Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02653144

2015-5628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• ASA 1 and 2
• 18-60 years old
• Patients scheduled for ambulatory arthroscopic or open surgery

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

dexmedetomidine and ropivacaine group

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Dexmedetomidine

dexamethasone and ropivacaine group

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Dexamethasone

ropivacaine only group

Active Comparator group

Description:

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)

Treatment:

Drug: Ropivacaine