Dexmedetomidine Added to Ropivacaine Single Shot vs Continuous Interscalene Nerve Block for Elective Arthroscopic Shoulder Surgery: a Prospective Randomized Control Trial

2022-2892

Arthroscopic shoulder surgery is increasingly performed in an outpatient setting and post-operative pain management is often a real challenge as those surgeries are well recognized for their high level of pain which often affects physical rehabilitation. The interscalene block is a largely used anesthetic technique to perform these surgeries whilst avoiding general anesthesia (GA) and to provide postoperative analgesia. However, the painful period often exceeds the duration of a single shot block, thus affecting patient recovery. Some specialized centers use a continuous catheter and elastomeric pump in order to prolong the duration of analgesia. However, several logistical, professional and financial constraints limit the use of these catheters and pumps in a great number of outpatient centers. On the other hand, perineural dexmedetomidine is increasingly used as an adjuvant to improve block onset, analgesia duration and patient satisfaction. The use of adjuvants such as perineural dexmedetomidine added to a single shot interscalene block appears to be an interesting option to prolong postoperative analgesia without the limitations imposed by a continuous catheter and elastomeric pumps in arthroscopic shoulder surgeries.

2022-08-23

2025-01-01

2025-06-01

Recruiting

96

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients will be first met either at our preoperative investigation clinic or by phone in the days leading to surgery to present the project and obtain consent. Consent will be dynamic and participants will have the possibility to withdraw from the study at all times.\n\nA web-based inclusion and randomization form will be provided to the investigators. Randomization will be done in a 1:1 ratio. Envelopes will be made, one for each patient, and will contain the randomization information and in which group they are in: D in the single shot dexmedetomidine added to ropivacaine or R for the continuous interscalene brachial plexus block with ropivacaine.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "The patient, the anesthesiologist that will perform the block and the operating room staff cannot be blinded for treatment group allocation since the material differs in the 2 groups. We did not want to remain blind at all costs by installing catheters in all participants, with a continuous infusion of saline for the dexmedetomidine group, since the insertion of a catheter is not without risk for the patient and the initial bolus would have been diluted.\n\nThe nurse staff, anesthesiologists and the research staff evaluating the patient by phone on postoperative days 1,2 and 3 will not be blinded to the patients' study care group allocation because they will also be looking for minor complications that involve the catheter or the infusion pump."}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2024-02-20