Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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 Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Brachial Plexus Block in Patients Receiving a Large Multimodal Analgesia: a Randomized Controlled Trial 

Conditions
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Analgesia

Intervention / Treatment
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* Drug: ropivacaine 0.2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CI group<br>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. | Drug: ropivacaine 0.2%<br>* continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.<br>|
| No Intervention: SS group<br>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. After the injection, the catheter will be removed. 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total i.v. morphine consumption | i.v morphine consumption in milligrams | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total i.v. morphine consumption postoperative | i.v morphine consumption in milligrams | in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively | 
| pain scores at rest and on movement | Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain). | in the postoperative care unit, and twice a day during the first 48 hours postoperatively | 
| presence of PONV | verbal question to the patient if he has PONV or not | in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively | 
| presence of pruritus | verbal question to the patient if he has pruritus or not | in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively | 
| overall patient satisfaction rate | Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction) | at 24 hours and 48 hours postoperatively | 
| length of hospital stay | in days | From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months | 
| rate of complications related to the catheter | infection at puncture point, catheter accidental removal | From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months | 
| joint amplitude during anterior elevation of the shoulder | Evaluated by physiotherapists | at 24 hours and 48 hours postoperatively | 
| joint amplitude during shoulder abduction | Evaluated by physiotherapists | at 24 hours and 48 hours postoperatively | 
| joint amplitude during external rotation of the shoulder | Evaluated by physiotherapists | at 24 hours and 48 hours postoperatively | 
| pain score | Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain). | at 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, Brachial plexus block, Shoulder surgery, Local anesthetics, Multimodal analgesia