CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
NCT Number: NCT04394130
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
Time frame: 24 hours postoperatively
i.v morphine consumption in milligrams
Time frame: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
i.v morphine consumption in milligrams
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: at 24 hours and 48 hours postoperatively
Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)
Time frame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
in days
Time frame: 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
Time frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
Time frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
Time frame: at 24 hours and 48 hours postoperatively
Evaluated by physiotherapists
Time frame: at 3 months postoperatively
Via phone contact. Numeric pain intensity scale. Pain scores range from 0 (no pain) to 10 (worst possible pain).
Eric Albrecht
Other
" 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 "
Acronym: BIGKIS
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