Comparing two methods of pain management for shoulder surgery
Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block for Elective Arthroscopic Shoulder Surgery: a Prospective Randomized Control Trial
This study is testing whether adding a medication called dexmedetomidine to a pain block can help people having shoulder surgery feel less pain and be more satisfied compared to a different type of pain management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05775861 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding dexmedetomidine to ropivacaine in a single shot interscalene brachial plexus block compared to a continuous interscalene block for patients undergoing elective arthroscopic shoulder surgery. The study aims to address the challenge of postoperative pain management, which is critical for recovery and rehabilitation. By comparing these two approaches, the trial seeks to determine which method provides better pain control and patient satisfaction in an outpatient setting. The trial will include patients over 18 years old who are scheduled for same-day discharge after surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old undergoing elective arthroscopic shoulder surgery who can return home the same day.
Not a fit: Patients who may not benefit include those requiring general anesthesia, those with contraindications to nerve blocks, or those unable to communicate effectively with the investigators.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing shoulder surgery, enhancing recovery and rehabilitation.
How similar studies have performed: Previous studies have shown that continuous interscalene blocks provide superior pain relief compared to single shot blocks, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * ASA status of I-III * Patients undergoing elective arthroscopic ambulatory shoulder surgery * Anticipated return home the same day (less than 12 hours in-hospital) in any operating theater of the CIUSSS. Exclusion Criteria: * less than 18 years old * Patient refusal * Pregnancy * Patients with known allergy to local anesthetics * Contraindication to interscalene brachial plexus nerve block or superficial cervical plexus block: coagulopathy, contralateral phrenic nerve dysfunction, infection at the puncture site, severe chronic obstructive pulmonary disease * Technical inability to proceed with the interscalene brachial plexus nerve block * Surgery requiring general anesthesia * Body weight less than 50 kg * Patient with no family member or caring adult at home during the first 72h postoperative (contraindication to elastomeric pump) * Unable to communicate with the investigators, unable to read the questionnaire, unable to keep track and notes of the medication taken at home * Significant psychiatric or cognitive condition interfering with the ability to provide consent or assessment * Preexisting neurologic deficits or neuropathy affecting the brachial plexus * Any contra-indication to same-day surgery identified by the pre-operative clinic such as, but not limited to, any cognitive disorder, any physical limitation other than the one leading to surgery that might impair the patient to take care of himself/herself at home, any severe pulmonary or cardiac disorder, bleeding disorder, etc, * Any cardiac or pulmonary condition that precludes the risk of bradycardia or hypotension such as but not limited to symptomatic coronary disease, severe aortic stenosis, moderate to severe pulmonary hypertension, congestive heart failure, second or third degree block, pre-existing bradycardia (HR lower than 50), pre-existing hypotension (SBP lower than 100 mmHg), etc. * History of chronic pain with daily opioid use during the 3 months before surgery
Where this trial is running
Montreal, Quebec
- CIUSSS de l'Est de l'Ile de Montreal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ariane Clairoux, MD — Ciusss de L'Est de l'Île de Montréal
- Study coordinator: Ariane AC Clairoux, MD, FRCPC
- Email: ariane.clairoux@umontreal.ca
- Phone: 5142226743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.