ClinicalTrials.gg
RecruitingNCT07146685RPRCTUpdated Sep 9, 2026

Effect of Local Anesthetic Concentration on Rebound Pain

A Phase 4 interventional study of Bupivacaine in Rebound Pain, Shoulder Arthroplasty and Interscalene Block, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University of Virginia · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 146 studies testing bupivacaine in Pain — 19 open to participants now, 19 under way, 3 of them phase 3. Bupivacaine · Pain.

Planned enrollment
132nd of 146
10 · median 63
Started
2026
with 5 others
Phase 4
55 of 146
6 open now
Primary completion
2028-01
later than 17 of 18 live
Registered
138th of 146
by date

Among the 146 studies testing bupivacaine in Pain, this one is the 132nd largest by planned enrollment, is one of 6 that started in 2026, is one of 55 in phase 4, reaches primary completion later than 17 of the 18 other live ones, and was the 138th registered.

By phase

146 studies; the count open now beside each. This study's row is marked.

Phase 4this study55 · 6 open
No phase46 · 9 open
Phase 317 · 1 open
Phase 214 · 0 open
Phase 18 · 1 open
Phase 2/35 · 2 open
Phase 1/21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 63 across the 146 interventional studies. Of the 102 that completed or were terminated, 53 (52%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 146 studies testing bupivacaine in Pain, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Rebound Pain
  • Shoulder Arthroplasty
  • Interscalene Block

Browse trials for

Keywords

  • local anesthetics
  • rebound pain
  • brachial plexus
  • shoulder arthroscopy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Total shoulder replacement patients (anatomic and reverse)
  • Adult patients (greater than or equal to 18 years)
  • Any gender
  • Any race

Exclusion criteria

Exclusion Criteria:

  • - 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
  • Respiratory pathologies including:
  • CPAP- non-compliant / untreated obstructive sleep apnea
  • Restrictive lung disease (pulmonary fibrosis, interstitial pneumonia, etc)
  • Contralateral diaphragm dysfunction
  • > 40
  • Ipsilateral extremity pre-existing nerve injury
  • \< 60
  • NSAID
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    Concentrated

    Standard management of higher percent local anesthetic: 0.5% Bupivacaine

    Drug: Bupivacaine

  • Experimental
    Dilute

    More dilute local : 0.25% Bupivacaine

    Drug: Bupivacaine

Interventions

  • 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours after intervention

Secondary outcomes

  1. Qor15 score questionnaire.

    Patient will answer QoR15 questionnaire

    Time frame: 24, 48 and 72 hours.

  2. 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.

    Time frame: 24, 48, 72 hours

  3. Opioid Use

    Total doses used will be converted to Morphine Milligram Equivalents

    Time frame: Assessed at 72 hours

  4. Sensory Block Duration

    The Investigator will ask the patient how long they felt the nerve block was effective, in terms of hours.

    Time frame: Assessed at 24 hours.

  5. 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.

    Time frame: Assessed at 24 hours.

  6. Presence of Nausea or Vomiting

    The investigators will ask the patient if there was any incidence of nausea or vomiting.

    Time frame: 24, 48, 72 hours

  7. Presence of persistent paresthesia

    The investigators will ask the patient if there is any presence of persistent paresthesia.

    Time frame: 24, 48, and 72 hours.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 9773699 ↗
  • Fredrickson 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 22664978 ↗
  • Lee 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 37337808 ↗
  • Woo 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 34535548 ↗
  • Uppal 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 37833472 ↗
  • Barry 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 33390261 ↗
  • Abdallah 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 25822923 ↗
  • Lavand'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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07146685
Responsible party
Leon Grinman (Assistant Professor, University of Virginia) — Principal investigator
First posted
Aug 28, 2025
Start date
May 13, 2026
Primary completion
Jan 28, 2028 (estimated)
Completion
Jan 28, 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Leon N Grinman, DO
Contact
Lngrinman@gmail.com
434-924-3627
Brett Elmore, MD
Contact
elmorbr@gmail.com
434-924-3627
Leon N Grinman, DO
principal investigator · UVA

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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