- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394130
Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Block (BIGKIS)
" 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 Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- CHUV
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CI group
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. |
continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
|
NO_INTERVENTION: SS group
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total i.v. morphine consumption
Time Frame: 24 hours postoperatively
|
i.v morphine consumption in milligrams
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total i.v. morphine consumption postoperative
Time Frame: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
|
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
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).
|
in the postoperative care unit, and twice a day during the first 48 hours postoperatively
|
presence of PONV
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
|
in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
|
presence of pruritus
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
|
in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively
|
overall patient satisfaction rate
Time Frame: at 24 hours and 48 hours postoperatively
|
Numeric rating scale ranging from 0 (totally dissatisfied) to 10 (maximal satisfaction)
|
at 24 hours and 48 hours postoperatively
|
length of hospital stay
Time Frame: From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months
|
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
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
|
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
Time Frame: at 24 hours and 48 hours postoperatively
|
Evaluated by physiotherapists
|
at 24 hours and 48 hours postoperatively
|
joint amplitude during shoulder abduction
Time Frame: at 24 hours and 48 hours postoperatively
|
Evaluated by physiotherapists
|
at 24 hours and 48 hours postoperatively
|
joint amplitude during external rotation of the shoulder
Time Frame: at 24 hours and 48 hours postoperatively
|
Evaluated by physiotherapists
|
at 24 hours and 48 hours postoperatively
|
pain score
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).
|
at 3 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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