Clinical trial NCT04394130: Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block
Official title: " 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 "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Regional anesthesia
Brachial plexus block
Shoulder surgery
Local anesthetics
Multimodal analgesia
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: total i.v. morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: total i.v. morphine consumption postoperative
timeFrame: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
measure: pain scores at rest and on movement
timeFrame: in the postoperative care unit, and twice a day during the first 48 hours postoperatively
measure: presence of PONV
timeFrame: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
measure: presence of pruritus
timeFrame: in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
measure: overall patient satisfaction rate
timeFrame: at 24 hours and 48 hours postoperatively
measure: length of hospital stay
timeFrame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
measure: rate of complications related to the catheter
timeFrame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
measure: joint amplitude during anterior elevation of the shoulder
timeFrame: at 24 hours and 48 hours postoperatively
measure: joint amplitude during shoulder abduction
timeFrame: at 24 hours and 48 hours postoperatively
measure: joint amplitude during external rotation of the shoulder
timeFrame: at 24 hours and 48 hours postoperatively
measure: pain score
timeFrame: at 3 months postoperatively
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: CHUV
name: Eric Albrecht
role: PRINCIPAL_INVESTIGATOR
References: