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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI group | Experimental | 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. |
|
| SS group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine 0.2% | Drug | continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative. |
|
| Measure | Description | Time Frame |
|---|---|---|
| total i.v. morphine consumption | i.v morphine consumption in milligrams | 24 hours postoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Albrecht | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37541683 | Derived | Rhyner P, Cachemaille M, Goetti P, Rossel JB, Boand M, Farron A, Albrecht E. Single-bolus injection of local anesthetic, with or without continuous infusion, for interscalene brachial plexus block in the setting of multimodal analgesia: a randomized controlled unblinded trial. Reg Anesth Pain Med. 2024 May 7;49(5):313-319. doi: 10.1136/rapm-2023-104681. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |