Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block
- Registration Number
- NCT04394130
- Lead Sponsor
- Eric Albrecht
- Brief Summary
The aim of this study is to study the analgesic efficacy of a continuous infusion of local anaesthetics for interscalene brachial plexus block after major shoulder surgery in the setting of multimodal analgesia, in order to determine whether the use of a catheter is still necessary in a contemporary practice.
- Detailed Description
The hypothesis of this study is that in contemporary practice, comprising the administration of multimodal analgesia, the continuous infusion of local anesthetic via a catheter remains superior in terms of analgesia at 24 h compared to a single-shot injection at the level of the interscalene brachial plexus after major shoulder surgery.
This prospective randomized monocentric superiority study will include two parallel groups: a SS (single-shot injection) group and a CI (continuous infusion) group.
All patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. In the SS group, the catheter will be removed. In the CI group, a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration of ropivacaine 0.5%.
In both groups, patients will receive during surgery multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.
Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.
In the postoperative period, patients will be prescribed an iv pca of morphine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patient scheduled for a major shoulder surgery (total shoulder arthroplasty or rotator cuff repair);
- ASA class 1 to 3;
- age more than 18 years old.
- patient refusal or inability to understand and/or sign the inform consent
- contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm);
- chronic alcool abuse;
- chronic pain under chronic opioid treatment
- opioid drug abuse or under substitution treatment
- patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
- patients under chronic corticotherapy
- patients known for malignant hyperthermia;
- patients with chronic kidney failure class 3 or more;
- patients with severe pulmonary disease;
- patients with history of neck surgery or radiotherapy on the operative side;
- pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CI group ropivacaine 0.2% Patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. Then a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration. During surgery, patients will also receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.
- Primary Outcome Measures
Name Time Method total i.v. morphine consumption 24 hours postoperatively i.v morphine consumption in milligrams
- Secondary Outcome Measures
Name Time Method overall patient satisfaction rate at 24 hours and 48 hours postoperatively Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)
length of hospital stay From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months in days
pain score at 3 months postoperatively Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
presence of PONV in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively verbal question to the patient if he has PONV or not
joint amplitude during anterior elevation of the shoulder at 24 hours and 48 hours postoperatively Evaluated by physiotherapists
joint amplitude during shoulder abduction at 24 hours and 48 hours postoperatively Evaluated by physiotherapists
total i.v. morphine consumption postoperative in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively i.v morphine consumption in milligrams
pain scores at rest and on movement in the postoperative care unit, and twice a day during the first 48 hours postoperatively Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
presence of pruritus in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively verbal question to the patient if he has pruritus or not
rate of complications related to the catheter From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months infection at puncture point, catheter accidental removal
joint amplitude during external rotation of the shoulder at 24 hours and 48 hours postoperatively Evaluated by physiotherapists
Trial Locations
- Locations (1)
CHUV
🇨🇭Lausanne, Vaud, Switzerland