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Dexmedetomidine + Ropivacaine for Shoulder Pain and Postoperative Pain (DEXBIB Trial)

N/A

Recruiting

Led By Ariane Clairoux, MD

Research Sponsored by Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery period (intraoperative)

Awards & highlights

DEXBIB Trial Summary

This trial shows that a single-shot interscalene block with perineural dexmedetomidine can improve post-op pain relief in arthroscopic shoulder surgeries.

Who is the study for?

Adults over 18, with a health status of ASA I-III, undergoing elective outpatient shoulder surgery and returning home the same day. Excluded are those under 18 or weighing less than 50 kg, without post-op support at home for the first 72 hours, communication issues, significant psychiatric/cognitive conditions, severe medical disorders like heart disease or bleeding problems, chronic pain with daily opioid use in past three months, pregnancy, need for general anesthesia during surgery.Check my eligibility

What is being tested?

The trial is testing two methods to manage pain after shoulder surgery: one group receives a single shot of ropivacaine mixed with dexmedetomidine (a sedative), while another gets continuous pain relief through a catheter. The goal is to see if adding dexmedetomidine can extend pain relief without needing complex equipment.See study design

What are the potential side effects?

Possible side effects include low blood pressure (hypotension), slow heart rate (bradycardia), reactions at the injection site such as infection or irritation. Dexmedetomidine may also cause drowsiness or dry mouth.

DEXBIB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours and 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours and 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary endpoint will be the Quality of Recovery (QoR-15) questionnaire score from minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery) at 48 hours postoperative.

Secondary outcome measures

Incidence of side effects related to dexmedetomidine in PACU: bradycardia.

Incidence of side effects related to dexmedetomidine in PACU: hypotension

Major and minor complications

+11 more

DEXBIB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: single shot interscalene brachial plexus with dexmedetomidine added to ropivacaineExperimental Treatment1 Intervention

A total of 150 mg of ropivacaine 0.5% will be prepared, 125 mg (25mL) will be mixed with a dose of 2 mcg/kg IBW of dexmedetomidine (100 mcg/mL dexmedetomidine hydrochloride; Precedex, Hospira Inc, Lake Forest, IL). The total of 25 mL (125 mg or ropivacaine 0.5%) with dexmedetomidine will be injected perineurally at the level of the roots and a 5 mL (25 mg) will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block.

Group II: continuous interscalene brachial plexus block with ropivacaineActive Control1 Intervention

A total of 100 mg (20 mL) of ropivacaine 0,5% will be injected perineurally at the level of the roots using the Tuohy needle. The 19 G arrow catheter will then be introduced through the Tuohy needle and we will leave 4 cm of the catheter perineurally. An additional 25 mg (5 mL) of ropivacaine 0,5% will be injected using the catheter to make sure the catheter is in a correct position. An additional 5 mL (25 mg) of ropivacaine 0.5 % will be injected between the sternocleidomastoid muscle and anterior scalene for the superficial cervical plexus block using an ultrasound in-plane approach with a 22 G 80-mm ultrasound needle (Pajunk SonoTAP II, Germany) or with a standard 25G 1 1/2 inches needle. After the surgery, an infusion of ropivacaine 0,2% at a standard rate of 5 mL/h will be started using an elastomeric pump of 300 mL (Baxter Corporation, Mississauga, Ontario).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor

70 Previous Clinical Trials

5,464 Total Patients Enrolled

Ariane Clairoux, MDPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal

2 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Continuous Interscalene Brachial Plexus Block Clinical Trial Eligibility Overview. Trial Name: NCT05775861 — N/A

Shoulder Pain Research Study Groups: single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine, continuous interscalene brachial plexus block with ropivacaine

Shoulder Pain Clinical Trial 2023: Continuous Interscalene Brachial Plexus Block Highlights & Side Effects. Trial Name: NCT05775861 — N/A

Continuous Interscalene Brachial Plexus Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05775861 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants needed for this investigation?

"Clinicaltrials.gov currently lists this medical trial as actively recruiting patients, in spite of its initial posting date on August 23rd 2022 and latest edit done on March 7th 2023."

Answered by AI

What is the numerical scope of participants in this medical research endeavor?

"Affirmative. Clinicaltrials.gov records illustrate that since August 23rd 2022, this clinical trial has been actively recruiting participants from a single location to fill 96 patient spots."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block

Ariane Clairoux 2022. "Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05775861.