Respiratory Impact of LA Volume After IS Block
- Conditions
- Arthroscopic Surgery of the ShoulderExtrafascial Interscalene Plexus Brachial Block
- Interventions
- Registration Number
- NCT04726280
- Lead Sponsor
- Eric Albrecht
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- arthroscopic surgery of the shoulder
- ASA class 1 to 3
- age more than 18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20 ml single-shot injection group 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. 10 ml single-shot injection Ropivacaine 0.75% Injectable Solution 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.
- Primary Outcome Measures
Name Time Method Incidence of hemidiaphragmatic paralysis 30 minutes after the interscalene plexus brachial extrafascial injection
- Secondary Outcome Measures
Name Time Method Duration of motor block up to 24 hours postsurgery in minutes
Duration of sensory block up to 24 hours postsurgery in minutes
Presence of Dyspnea in phase 1 recovery and at 12 and 24 postoperative Verbal question to the patient if he has dyspnea or not
Installation time of sensory block up to 30 minutes after the interscalene plexus brachial extrafascial injection in minutes
Installation time of motor block up to 30 minutes after the interscalene plexus brachial extrafascial injection in minutes
Cumulative postoperative iv morphine consumption in phase 1 recovery and at 12 and 24 postoperative hours in milligrams
Forced vital capacity 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours in liters
Incidence of hemidiaphragmatic paralysis at 2 and 24 postoperative hours Presence of PONV in phase 1 recovery and at 12 and 24 postoperative Verbal question to the patient if he has dyspnea or not
Presence of Pruritus in phase 1 recovery and at 12 and 24 postoperative hours Verbal question to the patient if he has pruritus or not
Presence of Claude-Bernard-Horner syndrome in phase 1 recovery and at 12 and 24 postoperative hours Examination of the patient
Presence of Dysphonia in phase 1 recovery and at 12 and 24 postoperative hours Verbal question to the patient if he has dysphonia or not
Forced expiratory volume in one second 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours in liters per second
Peak expiratory flow 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours in liters per second
Time to first dose of postoperative iv morphine up to 24 hours postsurgery in hours
Pain scores at rest 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)
Pain scores on movement 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).
Duration of analgesic block up to 24 hours postsurgery in minutes
Satisfaction of the participants at 24 postoperative hours Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).
Trial Locations
- Locations (1)
CHUV (Centre Hospitalier Universitaire Vaudois)
🇨ðŸ‡Lausanne, Vaud, Switzerland