CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Canton of Vaud, 1011, Switzerland
NCT Number: NCT04726280
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lausanne, Canton of Vaud, 1011, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 ml extrafascial interscalene brachial plexus block
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection
Time frame: at 2 and 24 postoperative hours
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Verbal question to the patient if he has dyspnea or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Verbal question to the patient if he has dyspnea or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Verbal question to the patient if he has pruritus or not
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Examination of the patient
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Verbal question to the patient if he has dysphonia or not
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
in liters per second
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
in liters
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
in liters per second
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
in minutes
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
in minutes
Time frame: up to 24 hours postsurgery
in hours
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
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
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
in milligrams
Time frame: up to 24 hours postsurgery
in minutes
Time frame: up to 24 hours postsurgery
in minutes
Time frame: up to 24 hours postsurgery
in minutes
Time frame: at 24 postoperative hours
Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).
Eric Albrecht
Other
Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
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