Post Operative PainPhase 4NCT05868993
Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block
A Phase 4 study testing Dose of 0.5% Ropivacaine in people with Post Operative Pain, run by Benaroya Research Institute at 1 site in United States.
Trial summary
Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Dose of 0.5% Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical candidate for Arthroscopic rotator cuff surgery
- ASA I-III
- BMI<40
- Age >18
Who cannot join
- Inability to give informed consent
- Inability to complete consent process in English
- allergy to ropivacaine
- neuropathy
- contraindications to peripheral nerve block per ASRA guidelines
- chronic opioid use
Show all 9Show fewer
- infection at the injection/catheter site
- limb restriction due to medical history
- history of moderate - severe lung disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
David B Auyong, MD, 206-223-6980, David.Auyong@virginiamason.org
David B Auyong, MD
About this study
Official title: Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery
Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.
Read the detailed description
Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.
- Conditions
- Post Operative Pain
- Being tested
- Dose of 0.5% Ropivacaine
- Keywords
- brachial plexus block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of 0.5% RopivacaineDrug
Dose varied by 5mL of 0.5% Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Brachial Plexus Block Group 1 | Experimental | Interscalene Receives: Drug: Dose of 0.5% Ropivacaine |
| Brachial Plexus Group 2 | Experimental | Supraclavicular Receives: Drug: Dose of 0.5% Ropivacaine |
| Brachial Plexus Group 3 | Experimental | Suprascapular Receives: Drug: Dose of 0.5% Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Success
Block success measured by pain (11-point VAS)
Measured: 60min after surgery
Lung Function
Block success as measured by preservation of lung function (Vital Capacity in L)
Measured: 60 mins after surgery
Block Success
Block Success measured by opioid (mcg of fentanyl delivered)
Measured: 60 mins after surgery
Secondary outcomes (4)
Diaphragm Excursion
Change in Movement of Diaphragm in cm
Measured: 60 minutes after surgery
Vital Capacity
Change in Vital Capacity measured in L
Measured: 60 minutes after surgery
Pulse Oximetry
Change in Pulse Oximetry Value
Measured: 60 minutes after surgery
Side Effects
Rate of Dyspnea, Horner's, Hoarseness
Measured: 60 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start17 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868993
- Sponsor's protocol ID
- IRB20-018
- Status last verified
- Feb 2023
- First submitted
- 27 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05868993
- Acronym / sponsor ID
- IRB20-018
- Conditions
- Post Operative Pain
- Keywords
- brachial plexus block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 May 2023 (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.
Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.
Detailed description
Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brachial Plexus Block Group 1 | Experimental | Drug: Dose of 0.5% RopivacaineInterscalene |
| Brachial Plexus Group 2 | Experimental | Drug: Dose of 0.5% RopivacaineSupraclavicular |
| Brachial Plexus Group 3 | Experimental | Drug: Dose of 0.5% RopivacaineSuprascapular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical candidate for Arthroscopic rotator cuff surgery
- ASA I-III
- BMI<40
- Age >18
Key exclusion criteria (9 listed)
- Inability to give informed consent
- Inability to complete consent process in English
- allergy to ropivacaine
- neuropathy
- contraindications to peripheral nerve block per ASRA guidelines
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 |
|---|---|---|
| Dose of 0.5% RopivacaineDose varied by 5mL of 0.5% Ropivacaine | Drug | Brachial Plexus Block Group 1, Brachial Plexus Group 2, Brachial Plexus Group 3 |
Primary outcome
Block Success
Time frame: 60min after surgery
Block success measured by pain (11-point VAS)
Lung Function
Time frame: 60 mins after surgery
Block success as measured by preservation of lung function (Vital Capacity in L)
Block Success
Time frame: 60 mins after surgery
Block Success measured by opioid (mcg of fentanyl delivered)
4 secondary outcomes
Diaphragm Excursion
Time frame: 60 minutes after surgery
Vital Capacity
Time frame: 60 minutes after surgery
Pulse Oximetry
Time frame: 60 minutes after surgery
Side Effects
Time frame: 60 minutes after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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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.
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 Dose of 0.5% Ropivacaine in people with Post Operative Pain, run by Benaroya Research Institute at 1 site in United States.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 May 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Auyong (206-223-6980, anedba@vmmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block Success (time frame: 60min after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.