An interventional study of ropivacaine 0.2% in Analgesia, sponsored by Eric Albrecht. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Eric Albrecht · Not applicable, Interventional, and Treatment
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.
Eric Albrecht is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ropivacaine 0.2%
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.
continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
total i.v. morphine consumption
i.v morphine consumption in milligrams
Time frame: 24 hours postoperatively
total i.v. morphine consumption postoperative
i.v morphine consumption in milligrams
Time frame: in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively
pain scores at rest and on movement
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 during the first 48 hours postoperatively
presence of PONV
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
presence of pruritus
verbal question to the patient if he has pruritus or not
Time frame: 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)
Time frame: at 24 hours and 48 hours postoperatively
length of hospital stay
in days
Time frame: 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
Time frame: 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
Time frame: at 24 hours and 48 hours postoperatively
joint amplitude during shoulder abduction
Evaluated by physiotherapists
Time frame: at 24 hours and 48 hours postoperatively
joint amplitude during external rotation of the shoulder
Evaluated by physiotherapists
Time frame: 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).
Time frame: at 3 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Aug 2022, 27 months.
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Studies of the drug tested here: Ropivacaine
Agnosia
Eric Albrecht