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single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine for Anesthesia

CIUSSS de l'Est de l'Ile de Montreal, Montreal, Canada
Anesthesia+2 More Conditionssingle shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Eligible Conditions
  • Anesthesia
  • Postoperative Pain
  • Shoulder Pain

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Femoral Articular Branch Block
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Single Shot Regional Anesthesia Upper Limb Surgery
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Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 72 hours

Hour 72
QoR-15 at 24 hours and 72 hours
6 hours
Incidence of side effects related to dexmedetomidine in PACU: bradycardia.
Incidence of side effects related to dexmedetomidine in PACU: hypotension
72 hours
Major and minor complications
Patient satisfaction
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.
The presence of nausea and vomiting in the PACU and during the first three post-operative days.
Total post-operative opioid consumption
Hour 5
Total time from end of surgery to obtention of discharge criterias.
Hour 72
Time before the end of motor block
Time before the end of sensory block
Time before the first analgesic request
Surgery period (intraoperative)
Standardized intraoperative ketamine consumption (mg)
Standardized intraoperative opioid consumption (mcg of fentanyl)
Standardized intraoperative total dose of propofol used for sedation (mg).

Trial Safety

Phase-Based Safety

1 of 3

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1
Femoral Articular Branch Block
2
Single Shot Regional Anesthesia Upper Limb Surgery
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Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

continuous interscalene brachial plexus block with ropivacaine
1 of 2
single shot interscalene brachial plexus with dexmedetomidine added to ropivacai...
1 of 2

Active Control

Experimental Treatment

96 Total Participants · 2 Treatment Groups

Primary Treatment: single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine · No Placebo Group · N/A

single shot interscalene brachial plexus with dexmedetomidine added to ropivacaine
Drug
Experimental Group · 1 Intervention: single shot interscalene brachial plexus block group with dexmedetomidine added to ropivacaine group · Intervention Types: Drug
continuous interscalene brachial plexus block with ropivacaine
Drug
ActiveComparator Group · 1 Intervention: continuous interscalene brachial plexus block · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
60 Previous Clinical Trials
4,301 Total Patients Enrolled
Ariane Clairoux, MDPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
2 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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