Clinical trial NCT04726280: Respiratory Impact of LA Volume After IS Block
Official title: Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopic Surgery of the Shoulder
Extrafascial Interscalene Plexus Brachial Block
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* arthroscopic surgery of the shoulder
* 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
* 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 (Glomerular Filtration Rate \< 20 ml/min)
* patients with severe pulmonary disease
* patients with history of neck surgery or radiotherapy on the operative side;
* pregnancy

Primary outcomes:
measure: Incidence of hemidiaphragmatic paralysis
timeFrame: 30 minutes after the interscalene plexus brachial extrafascial injection
Secondary outcomes:
measure: Incidence of hemidiaphragmatic paralysis
timeFrame: at 2 and 24 postoperative hours
measure: Presence of Dyspnea
timeFrame: in phase 1 recovery and at 12 and 24 postoperative
measure: Presence of PONV
timeFrame: in phase 1 recovery and at 12 and 24 postoperative
measure: Presence of Pruritus
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Presence of Claude-Bernard-Horner syndrome
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Presence of Dysphonia
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Forced expiratory volume in one second
timeFrame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
measure: Forced vital capacity
timeFrame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
measure: Peak expiratory flow
timeFrame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
measure: Installation time of sensory block
timeFrame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
measure: Installation time of motor block
timeFrame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
measure: Time to first dose of postoperative iv morphine
timeFrame: up to 24 hours postsurgery
measure: Pain scores at rest
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Pain scores on movement
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Cumulative postoperative iv morphine consumption
timeFrame: in phase 1 recovery and at 12 and 24 postoperative hours
measure: Duration of analgesic block
timeFrame: up to 24 hours postsurgery
measure: Duration of motor block
timeFrame: up to 24 hours postsurgery
measure: Duration of sensory block
timeFrame: up to 24 hours postsurgery
measure: Satisfaction of the participants
timeFrame: at 24 postoperative hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV (Centre Hospitalier Universitaire Vaudois)
state: Vaud
Study officials:
References: