Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT05775861
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05775861
Study Brief:
Protocol Section:
NCT05775861