Rebound PainPhase 4RPRCTNCT07146685
Effect of Local Anesthetic Concentration on Rebound Pain
A Phase 4 study testing Bupivacaine in people with Rebound Pain and Shoulder Arthroplasty, run by University of Virginia at 1 site in United States.
Trial summary
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rebound Pain, Shoulder Arthroplasty, Interscalene Block
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 28 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Total shoulder replacement patients (anatomic and reverse)
- Adult patients (greater than or equal to 18 years)
- Any gender
- Any race
Who cannot join
- - Chronic Pain diagnoses including:
- substance/opioid use disorder
- complex regional pain syndromes
- fibromyalgia
- Daily persistent opioid use spanning 3 months prior to surgery date
- Allergy to local anesthetics or NSAIDS
Show all 21Show fewer
- Respiratory pathologies including:
- CPAP- non-compliant / untreated obstructive sleep apnea
- COPD
- Restrictive lung disease (pulmonary fibrosis, interstitial pneumonia, etc)
- Contralateral diaphragm dysfunction
- BMI > 40
- Ipsilateral extremity pre-existing nerve injury
- GFR < 60
- NSAID contraindications
- Inability to follow up
- Revision surgery
- Patients requesting block as primary (avoidance of general anesthesia)
- Need or request for brachial plexus catheter or liposomal bupivacaine
- Vulnerable populations (pregnancy, incarceration, etc)
- non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UVA Health
Charlottesville, Virginia, 22903
Leon N Grinman, DO, 434-924-3627, Lngrinman@gmail.com
About this study
Official title: Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty.
- Conditions
- Rebound Pain, Shoulder Arthroplasty, Interscalene Block
- Being tested
- Bupivacaine
- Keywords
- local anesthetics, rebound pain, brachial plexus, shoulder arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
We are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg).
| Study group | Role | What they receive |
|---|---|---|
| Concentrated | Active comparator | Standard management of higher percent local anesthetic: 0.5% Bupivacaine Receives: Drug: Bupivacaine |
| Dilute | Experimental | More dilute local : 0.25% Bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max NRS Pain Score at 24 hours
Pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Measured: 24 hours after intervention
Secondary outcomes (7)
Qor15 score questionnaire.
Patient will answer QoR15 questionnaire
Measured: 24, 48 and 72 hours.
Lowest NRS pain score
Lowest pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Measured: 24, 48, 72 hours
Opioid Use
Total doses used will be converted to Morphine Milligram Equivalents
Measured: Assessed at 72 hours
Sensory Block Duration
The Investigator will ask the patient how long they felt the nerve block was effective, in terms of hours.
Measured: Assessed at 24 hours.
Presence of dyspnea/shortness of breath
The investigator will ask the patient if they ever had trouble breathing or shortness of breath during the duration of the block.
Measured: Assessed at 24 hours.
Presence of Nausea or Vomiting
The investigators will ask the patient if there was any incidence of nausea or vomiting.
Measured: 24, 48, 72 hours
Presence of persistent paresthesia
The investigators will ask the patient if there is any presence of persistent paresthesia.
Measured: 24, 48, and 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start13 May 2026
- Primary completion28 Jan 2028 (estimated)
- Study completion28 Jan 2029 (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 Rebound PainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Grinman, University of Virginia
- Investigators
- Leon N Grinman, DO, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146685
- Sponsor's protocol ID
- HSR302714
- Acronym
- RPRCT
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared outside the study team. This is a small, exploratory pilot study intended to assess feasibility and generate preliminary data to inform a future, larger randomized trial.
Publications
Al-Kaisy A, McGuire G, Chan VW, Bruin G, Peng P, Miniaci A, Perlas A. Analgesic effect of interscalene block using low-dose bupivacaine for outpatient arthroscopic shoulder surgery. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):469-73.
PubMed 9773699Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.
PubMed 22664978Lee HJ, Woo JH, Chae JS, Kim YJ, Shin SJ. Intravenous Versus Perineural Dexamethasone for Reducing Rebound Pain After Interscalene Brachial Plexus Block: A Randomized Controlled Trial. J Korean Med Sci. 2023 Jun 19;38(24):e183. doi: 10.3346/jkms.2023.38.e183.
PubMed 37337808Woo JH, Lee HJ, Oh HW, Lee JW, Baik HJ, Kim YJ. Perineural dexamethasone reduces rebound pain after ropivacaine single injection interscalene block for arthroscopic shoulder surgery: a randomized controlled trial. Reg Anesth Pain Med. 2021 Nov;46(11):965-970. doi: 10.1136/rapm-2021-102795. Epub 2021 Sep 17.
PubMed 34535548Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13.
PubMed 37833472Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
PubMed 33390261Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.
PubMed 25822923Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
PubMed 30124544
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT07146685
- Acronym / sponsor ID
- RPRCT / HSR302714
- Conditions
- Rebound Pain, Shoulder Arthroplasty, Interscalene Block
- Keywords
- local anesthetics, rebound pain, brachial plexus, shoulder arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 28 Jan 2028 (estimated)
- Study completion
- 28 Jan 2029 (estimated)
- First posted
- 28 Aug 2025 (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.
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control study
| Arm | Type | Receives |
|---|---|---|
| Concentrated | Active comparator | Drug: BupivacaineStandard management of higher percent local anesthetic: 0.5% Bupivacaine |
| Dilute | Experimental | Drug: BupivacaineMore dilute local : 0.25% Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Total shoulder replacement patients (anatomic and reverse)
- Adult patients (greater than or equal to 18 years)
- Any gender
- Any race
Key exclusion criteria (21 listed)
- - Chronic Pain diagnoses including:
- substance/opioid use disorder
- complex regional pain syndromes
- fibromyalgia
- Daily persistent opioid use spanning 3 months prior to surgery date
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 |
|---|---|---|
| BupivacaineWe are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg). | Drug | Concentrated, Dilute |
Primary outcome
Max NRS Pain Score at 24 hours
Time frame: 24 hours after intervention
Pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
7 secondary outcomes
Qor15 score questionnaire.
Time frame: 24, 48 and 72 hours.
Lowest NRS pain score
Time frame: 24, 48, 72 hours
Opioid Use
Time frame: Assessed at 72 hours
Sensory Block Duration
Time frame: Assessed at 24 hours.
Presence of dyspnea/shortness of breath
Time frame: Assessed at 24 hours.
Presence of Nausea or Vomiting
Time frame: 24, 48, 72 hours
Presence of persistent paresthesia
Time frame: 24, 48, and 72 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 9773699Al-Kaisy A, McGuire G, Chan VW, Bruin G, Peng P, Miniaci A, Perlas A. Analgesic effect of interscalene block using low-dose bupivacaine for outpatient arthroscopic shoulder surgery. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):469-73.
- Background: PubMed 22664978Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.
- Background: PubMed 37337808Lee HJ, Woo JH, Chae JS, Kim YJ, Shin SJ. Intravenous Versus Perineural Dexamethasone for Reducing Rebound Pain After Interscalene Brachial Plexus Block: A Randomized Controlled Trial. J Korean Med Sci. 2023 Jun 19;38(24):e183. doi: 10.3346/jkms.2023.38.e183.
- Background: PubMed 34535548Woo JH, Lee HJ, Oh HW, Lee JW, Baik HJ, Kim YJ. Perineural dexamethasone reduces rebound pain after ropivacaine single injection interscalene block for arthroscopic shoulder surgery: a randomized controlled trial. Reg Anesth Pain Med. 2021 Nov;46(11):965-970. doi: 10.1136/rapm-2021-102795. Epub 2021 Sep 17.
- Background: PubMed 37833472Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13.
- Background: PubMed 33390261Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.
- Background: PubMed 25822923Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.
- Background: PubMed 30124544Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared outside the study team. This is a small, exploratory pilot study intended to assess feasibility and generate preliminary data to inform a future, larger randomized trial.
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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.
Leon N Grinman, DO principal investigator
UVA
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 Bupivacaine in people with Rebound Pain and Shoulder Arthroplasty, run by University of Virginia 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 21 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leon N Grinman, DO (434-924-3627, Lngrinman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Max NRS Pain Score at 24 hours (time frame: 24 hours after intervention). 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 NCT07146685, 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 9 Sep 2026.