Arthroscopic Surgery of the ShoulderPhase 4NCT04726280
Respiratory Impact of LA Volume After IS Block
A Phase 4 study testing Ropivacaine 0.75% Injectable Solution in people with Arthroscopic Surgery of the Shoulder and Extrafascial Interscalene Plexus Brachial Block, run by Eric Albrecht at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Surgery of the Shoulder, Extrafascial Interscalene Plexus Brachial Block
- What is being tested?
- Ropivacaine 0.75% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 20 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthroscopic surgery of the shoulder
- ASA class 1 to 3
- age more than 18 years old
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
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.
Read the 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.
- Being tested
- Ropivacaine 0.75% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.75% Injectable SolutionDrug
10 ml extrafascial interscalene brachial plexus block
Ropivacaine 0.75% Injectable SolutionDrug
20 ml extrafascial interscalene brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| 10 ml single-shot injection | Experimental | 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. Receives: Drug: Ropivacaine 0.75% Injectable Solution |
| 20 ml single-shot injection group | Active comparator | 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. Receives: Drug: Ropivacaine 0.75% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hemidiaphragmatic paralysis
Measured: 30 minutes after the interscalene plexus brachial extrafascial injection
Secondary outcomes (19)
Incidence of hemidiaphragmatic paralysis
Measured: at 2 and 24 postoperative hours
Presence of Dyspnea
Verbal question to the patient if he has dyspnea or not
Measured: in phase 1 recovery and at 12 and 24 postoperative
Presence of PONV
Verbal question to the patient if he has dyspnea or not
Measured: in phase 1 recovery and at 12 and 24 postoperative
Presence of Pruritus
Verbal question to the patient if he has pruritus or not
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Claude-Bernard-Horner syndrome
Examination of the patient
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Dysphonia
Verbal question to the patient if he has dysphonia or not
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Forced expiratory volume in one second
in liters per second
Measured: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Forced vital capacity
in liters
Measured: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Peak expiratory flow
in liters per second
Measured: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Installation time of sensory block
in minutes
Measured: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Installation time of motor block
in minutes
Measured: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Time to first dose of postoperative iv morphine
in hours
Measured: up to 24 hours postsurgery
Pain scores at rest
Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain)
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Pain scores on movement
Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain).
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Cumulative postoperative iv morphine consumption
in milligrams
Measured: in phase 1 recovery and at 12 and 24 postoperative hours
Duration of analgesic block
in minutes
Measured: up to 24 hours postsurgery
Duration of motor block
in minutes
Measured: up to 24 hours postsurgery
Duration of sensory block
in minutes
Measured: up to 24 hours postsurgery
Satisfaction of the participants
Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).
Measured: at 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Surgery of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726280
- Sponsor's protocol ID
- 2020-02930
- Status last verified
- Nov 2023
- First submitted
- 22 Jan 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39855930
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
- ClinicalTrials.gov ID
- NCT04726280
- Acronym / sponsor ID
- 2020-02930
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 ml single-shot injection | Experimental | Drug: Ropivacaine 0.75% Injectable SolutionIn 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. |
| 20 ml single-shot injection group | Active comparator | Drug: Ropivacaine 0.75% Injectable SolutionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- arthroscopic surgery of the shoulder
- ASA class 1 to 3
- age more than 18 years old
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.75% Injectable Solution10 ml extrafascial interscalene brachial plexus block | Drug | 10 ml single-shot injection |
| Ropivacaine 0.75% Injectable Solution20 ml extrafascial interscalene brachial plexus block | Drug | 20 ml single-shot injection group |
Primary outcome
Incidence of hemidiaphragmatic paralysis
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection
19 secondary outcomes
Incidence of hemidiaphragmatic paralysis
Time frame: at 2 and 24 postoperative hours
Presence of Dyspnea
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Presence of PONV
Time frame: in phase 1 recovery and at 12 and 24 postoperative
Presence of Pruritus
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Claude-Bernard-Horner syndrome
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Presence of Dysphonia
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Forced expiratory volume in one second
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Forced vital capacity
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Peak expiratory flow
Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours
Installation time of sensory block
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Installation time of motor block
Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection
Time to first dose of postoperative iv morphine
Time frame: up to 24 hours postsurgery
Pain scores at rest
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Pain scores on movement
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Cumulative postoperative iv morphine consumption
Time frame: in phase 1 recovery and at 12 and 24 postoperative hours
Duration of analgesic block
Time frame: up to 24 hours postsurgery
Duration of motor block
Time frame: up to 24 hours postsurgery
Duration of sensory block
Time frame: up to 24 hours postsurgery
Satisfaction of the participants
Time frame: at 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 39855930Renard 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.75% Injectable Solution in people with Arthroscopic Surgery of the Shoulder and Extrafascial Interscalene Plexus Brachial Block, run by Eric Albrecht at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hemidiaphragmatic paralysis (time frame: 30 minutes after the interscalene plexus brachial extrafascial injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.