Respiratory Impact of LA Volume After IS Block

NCT ID: NCT04726280

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-11-20

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.

Conditions

Arthroscopic Surgery of the Shoulder; Extrafascial Interscalene Plexus Brachial Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

10 ml single-shot injection

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.

Group Type: EXPERIMENTAL

Ropivacaine 0.75% Injectable Solution

Intervention Type: DRUG

10 ml extrafascial interscalene brachial plexus block

20 ml single-shot injection group

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.75% Injectable Solution

Intervention Type: DRUG

20 ml extrafascial interscalene brachial plexus block

Interventions

Ropivacaine 0.75% Injectable Solution

10 ml extrafascial interscalene brachial plexus block

Intervention Type: DRUG

Ropivacaine 0.75% Injectable Solution

20 ml extrafascial interscalene brachial plexus block

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eric Albrecht

OTHER

Sponsor Role: lead

Responsible Party

Eric Albrecht

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Renard Y, Grape S, Gonvers E, Rossel JB, Goetti P, Albrecht E. Respiratory impact of local anaesthetic volume after interscalene brachial plexus block with extrafascial injection: a randomised controlled double-blinded trial. Br J Anaesth. 2025 Apr;134(4):1153-1160. doi: 10.1016/j.bja.2024.12.010. Epub 2025 Jan 23.

Reference Type: DERIVED

PMID: 39855930 (View on PubMed)

Other Identifiers

2020-02930

Identifier Type: -

Identifier Source: org_study_id