Respiratory Impact of LA Volume After IS Block

Arthroscopic Surgery of the Shoulder Clinical Trial

Official title:

Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726280
• Other study ID #: 2020-02930
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Surgery of the Shoulder
• Extrafascial Interscalene Plexus Brachial Block

Intervention

Drug:
• Ropivacaine 0.75% Injectable Solution
10 ml extrafascial interscalene brachial plexus block
• Ropivacaine 0.75% Injectable Solution
20 ml extrafascial interscalene brachial plexus block

Locations

Country	Name	City	State
Switzerland	CHUV (Centre Hospitalier Universitaire Vaudois)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Eric Albrecht

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hemidiaphragmatic paralysis		30 minutes after the interscalene plexus brachial extrafascial injection
Secondary	Incidence of hemidiaphragmatic paralysis		at 2 and 24 postoperative hours
Secondary	Presence of Dyspnea	Verbal question to the patient if he has dyspnea or not	in phase 1 recovery and at 12 and 24 postoperative
Secondary	Presence of PONV	Verbal question to the patient if he has dyspnea or not	in phase 1 recovery and at 12 and 24 postoperative
Secondary	Presence of Pruritus	Verbal question to the patient if he has pruritus or not	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Presence of Claude-Bernard-Horner syndrome	Examination of the patient	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Presence of Dysphonia	Verbal question to the patient if he has dysphonia or not	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Forced expiratory volume in one second	in liters per second	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Secondary	Forced vital capacity	in liters	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Secondary	Peak expiratory flow	in liters per second	30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Secondary	Installation time of sensory block	in minutes	up to 30 minutes after the interscalene plexus brachial extrafascial injection
Secondary	Installation time of motor block	in minutes	up to 30 minutes after the interscalene plexus brachial extrafascial injection
Secondary	Time to first dose of postoperative iv morphine	in hours	up to 24 hours postsurgery
Secondary	Pain scores at rest	Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain)	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Pain scores on movement	Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain).	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Cumulative postoperative iv morphine consumption	in milligrams	in phase 1 recovery and at 12 and 24 postoperative hours
Secondary	Duration of analgesic block	in minutes	up to 24 hours postsurgery
Secondary	Duration of motor block	in minutes	up to 24 hours postsurgery
Secondary	Duration of sensory block	in minutes	up to 24 hours postsurgery
Secondary	Satisfaction of the participants	Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).	at 24 postoperative hours