Shoulder PainNCT04930393
Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients
A study testing Nerve Block - either PECS II or axillary ring in people with Shoulder Pain, run by University of Southern California at 1 site in United States.
Trial summary
Our current standard of care is to perform an interscalene peripheral nerve block for patients receiving rotator cuff repair surgery as it is an effective opioid-free alternative for post-operative pain control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Nerve Block - either PECS II or axillary ring
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to May 2024
- Phase
- Interventional
- 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
- medically optimized patients who will undergo an elective surgery for an arthroscopic rotator cuff repair with open biceps tenodesis
Who cannot join
- women who are pregnant or breastfeeding, history of chronic opioid use, respiratory compromise, smokers, or allergy to local anesthetics or opioids.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Healthcare Center 3 - Keck Hospital of USC
Los Angeles, California, 90033
Paul Lee, MD, pauls.lee@med.usc.edu
About this study
Official title: A Randomized Double-blinded Study to Evaluate the Efficacy of PECS II Block Versus Intercostobrachial Ring Block in Patients Undergoing Arthroscopic Rotator Cuff Repair With Open Biceps Tenodesis
Our current standard of care is to perform an interscalene peripheral nerve block for patients receiving rotator cuff repair surgery as it is an effective opioid-free alternative for post-operative pain control. However, many of these repairs require a supplemental incision for an open biceps tenodesis, which is not covered by the interscalene block. The intercostobrachial nerve covers this incision and is targeted by an axillary ring block or a single shot nerve block in the fascial plane between the pectoralis minor and serratus anterior muscles (otherwise termed as a PECS II block). This study will attempt to delineate if one is superior in postoperative analgesia and mitigating intraoperative stimulation by comparing an axillary ring block to a PECS II block. Patients receiving a rotator cuff repair with biceps tenodesis without histories of chronic opioid use and respiratory compromise will be eligible to be enrolled in the study. All patients will receive an interscalene block and group 1 will receive a supplemental axillary ring block and group 2 will instead receive a PECS II block. After surgery, the patients' pain score will be assessed upon PACU arrival, at 6 hours after block, and 2 weeks postoperatively. Their opioid requirements will also be assessed. Our primary outcome is pain score at 6 hours following the block.
- Conditions
- Shoulder Pain
- Being tested
- Nerve Block - either PECS II or axillary ring
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Block - either PECS II or axillary ringProcedure or surgery
In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis
| Study group | Role | What they receive |
|---|---|---|
| PECS II Block | Active comparator | This group will receive an interscalene block in addition to a pectoral nerve block under ultrasound guidance with local anesthetic injected in the plane between the pectoralis minor and serratus anterior muscles Receives: Procedure: Nerve Block - either PECS II or axillary ring |
| Axillary Ring Block | Active comparator | This group will receive an interscalene block in addition to a ring block with local anesthetic injected subcutaneously along the axilla from anterior to posterior direction. Receives: Procedure: Nerve Block - either PECS II or axillary ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score at 6 hours following the block
Measured: 6 hours post-block
Secondary outcomes (2)
Morphine milligram equivalents (MME)
MMEs in recovery room after surgery and 2 weeks after surgery via phone call
Measured: Right after surgery and 2 weeks
Intraoperative Stimulation
Whether patient displayed signs of pain (movement, elevated blood pressure or heart rate) under moderate sedation in the operating room
Measured: 2 hours during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 Sep 2021
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S. Lee, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930393
- Sponsor's protocol ID
- HS-20-00980
- Status last verified
- Feb 2024
- First submitted
- 28 Apr 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho CH, Song KS, Min BW, Jung GH, Lee YK, Shin HK. Efficacy of interscalene block combined with multimodal pain control for postoperative analgesia after rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):542-7. doi: 10.1007/s00167-012-2272-3. Epub 2012 Oct 30.
PubMed 23108685Liu XN, Noh YM, Yang CJ, Kim JU, Chung MH, Noh KC. Effects of a Single-Dose Interscalene Block on Pain and Stress Biomarkers in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2017 May;33(5):918-926. doi: 10.1016/j.arthro.2016.09.018. Epub 2016 Dec 14.
PubMed 27988164Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
PubMed 21831090Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
PubMed 27543533Siddeshwara A, Singariya G, Kamal M, Kumari K, Seervi S, Kumar R. Comparison of efficacy of ultrasound-guided pectoral nerve block versus thoracic paravertebral block using levobupivacaine and dexamethasone for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):325-331. doi: 10.4103/sja.SJA_25_19.
PubMed 31572077Versyck B, van Geffen GJ, Chin KJ. Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):663-673. doi: 10.1111/anae.14607.
PubMed 30957884Reynolds JW, Henshaw DS, Jaffe JD, Dobson SW, Edwards CJ, Turner JD, Weller RS, Graves BR, Freehill MT. Analgesic Benefit of Pectoral Nerve Block II Blockade for Open Subpectoral Biceps Tenodesis: A Randomized, Prospective, Double-Blinded, Controlled Trial. Anesth Analg. 2019 Aug;129(2):536-542. doi: 10.1213/ANE.0000000000004233.
PubMed 31136331
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Study to Evaluate the Efficacy of PECS II Block Versus Intercostobrachial Ring Block in Patients Undergoing Arthroscopic Rotator Cuff Repair With Open Biceps Tenodesis
- ClinicalTrials.gov ID
- NCT04930393
- Acronym / sponsor ID
- HS-20-00980
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Jun 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.
Our current standard of care is to perform an interscalene peripheral nerve block for patients receiving rotator cuff repair surgery as it is an effective opioid-free alternative for post-operative pain control. However, many of these repairs require a supplemental incision for an open biceps tenodesis, which is not covered by the interscalene block. The intercostobrachial nerve covers this incision and is targeted by an axillary ring block or a single shot nerve block in the fascial plane between the pectoralis minor and serratus anterior muscles (otherwise termed as a PECS II block). This study will attempt to delineate if one is superior in postoperative analgesia and mitigating intraoperative stimulation by comparing an axillary ring block to a PECS II block. Patients receiving a rotator cuff repair with biceps tenodesis without histories of chronic opioid use and respiratory compromise will be eligible to be enrolled in the study. All patients will receive an interscalene block and group 1 will receive a supplemental axillary ring block and group 2 will instead receive a PECS II block. After surgery, the patients' pain score will be assessed upon PACU arrival, at 6 hours after block, and 2 weeks postoperatively. Their opioid requirements will also be assessed. Our primary outcome is pain score at 6 hours following the block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS II Block | Active comparator | Procedure: Nerve Block - either PECS II or axillary ringThis group will receive an interscalene block in addition to a pectoral nerve block under ultrasound guidance with local anesthetic injected in the plane between the pectoralis minor and serratus anterior muscles |
| Axillary Ring Block | Active comparator | Procedure: Nerve Block - either PECS II or axillary ringThis group will receive an interscalene block in addition to a ring block with local anesthetic injected subcutaneously along the axilla from anterior to posterior direction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medically optimized patients who will undergo an elective surgery for an arthroscopic rotator cuff repair with open biceps tenodesis
Key exclusion criteria (1 listed)
- women who are pregnant or breastfeeding, history of chronic opioid use, respiratory compromise, smokers, or allergy to local anesthetics or opioids.
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 |
|---|---|---|
| Nerve Block - either PECS II or axillary ringIn addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis | Procedure or surgery | Axillary Ring Block, PECS II Block |
Primary outcome
Visual Analog Score at 6 hours following the block
Time frame: 6 hours post-block
2 secondary outcomes
Morphine milligram equivalents (MME)
Time frame: Right after surgery and 2 weeks
Intraoperative Stimulation
Time frame: 2 hours during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 23108685Cho CH, Song KS, Min BW, Jung GH, Lee YK, Shin HK. Efficacy of interscalene block combined with multimodal pain control for postoperative analgesia after rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):542-7. doi: 10.1007/s00167-012-2272-3. Epub 2012 Oct 30.
- Background: PubMed 27988164Liu XN, Noh YM, Yang CJ, Kim JU, Chung MH, Noh KC. Effects of a Single-Dose Interscalene Block on Pain and Stress Biomarkers in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2017 May;33(5):918-926. doi: 10.1016/j.arthro.2016.09.018. Epub 2016 Dec 14.
- Background: PubMed 21831090Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
- Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Background: PubMed 27543533Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
- Background: PubMed 31572077Siddeshwara A, Singariya G, Kamal M, Kumari K, Seervi S, Kumar R. Comparison of efficacy of ultrasound-guided pectoral nerve block versus thoracic paravertebral block using levobupivacaine and dexamethasone for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):325-331. doi: 10.4103/sja.SJA_25_19.
- Background: PubMed 30957884Versyck B, van Geffen GJ, Chin KJ. Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):663-673. doi: 10.1111/anae.14607.
- Background: PubMed 31136331Reynolds JW, Henshaw DS, Jaffe JD, Dobson SW, Edwards CJ, Turner JD, Weller RS, Graves BR, Freehill MT. Analgesic Benefit of Pectoral Nerve Block II Blockade for Open Subpectoral Biceps Tenodesis: A Randomized, Prospective, Double-Blinded, Controlled Trial. Anesth Analg. 2019 Aug;129(2):536-542. doi: 10.1213/ANE.0000000000004233.
- 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 study testing Nerve Block - either PECS II or axillary ring in people with Shoulder Pain, run by University of Southern California 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 1 inclusion and 1 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 1 Mar 2024. 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.
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 Paul Lee, MD (4109132126, pauls.lee@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score at 6 hours following the block (time frame: 6 hours post-block). 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 NCT04930393, which also lists 8 linked publications.
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 1 Mar 2024.