Analgesia
Conditions
Keywords
Regional anesthesia, Brachial plexus block, Shoulder surgery, Local anesthetics, Multimodal analgesia
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.
Interventions
DRUGropivacaine 0.2%
continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
Sponsors
Eric Albrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total i.v. morphine consumption | 24 hours postoperatively | i.v morphine consumption in milligrams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| joint amplitude during external rotation of the shoulder | at 24 hours and 48 hours postoperatively | Evaluated by physiotherapists |
| 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). |
| 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 |
Countries
Switzerland
Outcome results
None listed