A Phase 4 interventional study of Ropivacaine 0.75% Injectable Solution and Ropivacaine 0.75% Injectable Solution in Arthroscopic Surgery of the Shoulder and Extrafascial Interscalene Plexus Brachial Block, sponsored by Eric Albrecht. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Eric Albrecht · Phase 4, Interventional, and Treatment
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.
All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg\^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.
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.
Eric Albrecht is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the 10ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 10 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg\^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.
Drug: Ropivacaine 0.75% Injectable Solution
In the 20ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 20 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg\^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.
Drug: Ropivacaine 0.75% Injectable Solution
10 ml extrafascial interscalene brachial plexus block
20 ml extrafascial interscalene brachial plexus block
Incidence of hemidiaphragmatic paralysis
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection
Incidence of hemidiaphragmatic paralysis
Time frame: at 2 and 24 postoperative hours
Presence of Dyspnea
Verbal question to the patient if he has dyspnea or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Presence of PONV
Verbal question to the patient if he has dyspnea or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Presence of Pruritus
Verbal question to the patient if he has pruritus or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Claude-Bernard-Horner syndrome
Examination of the patient
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Dysphonia
Verbal question to the patient if he has dysphonia or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Forced expiratory volume in one second
in liters per second
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Forced vital capacity
in liters
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Peak expiratory flow
in liters per second
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Installation time of sensory block
in minutes
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Installation time of motor block
in minutes
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Time to first dose of postoperative iv morphine
in hours
Time frame: up to 24 hours postsurgery
Pain scores at rest
Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain)
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Pain scores on movement
Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain).
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Cumulative postoperative iv morphine consumption
in milligrams
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Duration of analgesic block
in minutes
Time frame: up to 24 hours postsurgery
Duration of motor block
in minutes
Time frame: up to 24 hours postsurgery
Duration of sensory block
in minutes
Time frame: up to 24 hours postsurgery
Satisfaction of the participants
Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).
Time frame: at 24 postoperative hours
Plan to share: Undecided
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Studies of the drug tested here: Ropivacaine
Eric Albrecht