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

NCT02653144 | Completed Phase 4 Results DMC

• 1 other identifier: 2015-5628
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use, Unspecified

Keywords

post operative pain, Dexmedetomidine, Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid Requirements (Morphine Equivalents)

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

  24 hours

Secondary Outcomes (3)

• Opioid Requirements (Morphine Equivalents)

  48 hours

• Time to Discharge From PACU to First Opioid Consumption

  24-48 hours after surgery

• Return of Motor and Sensory Function

  24-48 hours after surgery

Study Arms (3)

dexmedetomidine and ropivacaine group

EXPERIMENTAL

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

Drug: Ropivacaine; Drug: Dexmedetomidine

dexamethasone and ropivacaine group

EXPERIMENTAL

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

Drug: Ropivacaine; Drug: Dexamethasone

ropivacaine only group

ACTIVE COMPARATOR

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)

Drug: Ropivacaine

Interventions

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

Also known as: anesthetics

dexamethasone and ropivacaine group; dexmedetomidine and ropivacaine group; ropivacaine only group

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

Also known as: anesthetics

dexmedetomidine and ropivacaine group

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

Also known as: anesthetics

dexamethasone and ropivacaine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (7)

• Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.

  PMID: 21956081 BACKGROUND

• Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

  PMID: 23161360 BACKGROUND

• Fritsch G, Danninger T, Allerberger K, Tsodikov A, Felder TK, Kapeller M, Gerner P, Brummett CM. Dexmedetomidine added to ropivacaine extends the duration of interscalene brachial plexus blocks for elective shoulder surgery when compared with ropivacaine alone: a single-center, prospective, triple-blind, randomized controlled trial. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):37-47. doi: 10.1097/AAP.0000000000000033.

  PMID: 24317234 BACKGROUND

• Esmaoglu A, Yegenoglu F, Akin A, Turk CY. Dexmedetomidine added to levobupivacaine prolongs axillary brachial plexus block. Anesth Analg. 2010 Dec;111(6):1548-51. doi: 10.1213/ANE.0b013e3181fa3095. Epub 2010 Oct 1.

  PMID: 20889939 BACKGROUND

• Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.

  PMID: 24310051 BACKGROUND

• Rasmussen SB, Saied NN, Bowens C Jr, Mercaldo ND, Schildcrout JS, Malchow RJ. Duration of upper and lower extremity peripheral nerve blockade is prolonged with dexamethasone when added to ropivacaine: a retrospective database analysis. Pain Med. 2013 Aug;14(8):1239-47. doi: 10.1111/pme.12150. Epub 2013 Jun 11.

  PMID: 23755801 BACKGROUND

• Williams BA, Schott NJ, Mangione MP, Ibinson JW. Perineural dexamethasone and multimodal perineural analgesia: how much is too much? Anesth Analg. 2014 May;118(5):912-4. doi: 10.1213/ANE.0000000000000203. No abstract available.

  PMID: 24781562 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Anesthetics; Dexmedetomidine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Amaresh Vydyanathan
• Organization: Montefiore Medical Center

avydyana@montefiore.org

7189204316

Study Officials

• Amaresh Vydyanathan, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Anesthesiology

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 27, 2018
• Last Updated: July 22, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)