Skip to main content
OpenTrials
Completed

NCT Number: NCT02653144

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use, Unspecified Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery

Other names: anesthetics

Dexmedetomidine

Drug

local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery

Other names: anesthetics

Dexamethasone

Drug

local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery

Other names: anesthetics

Primary outcomes

  1. Opioid Requirements (Morphine Equivalents)

    Time frame: 24 hours

    How much opioid did patient ask for within 24 hours post op

Secondary outcomes

  1. Opioid Requirements (Morphine Equivalents)

    Time frame: 48 hours

    How much opioid did patient ask for within 48 hours post op

  2. Time to Discharge From PACU to First Opioid Consumption

    Time frame: 24-48 hours after surgery

    How long after surgery does patient take to ask for opioid to manage pain

  3. Return of Motor and Sensory Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Double Blinded Randomized Controlled Study Evaluating the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block in Patients Undergoing Ambulatory Shoulder Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2016
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.