ClinicalTrials.gg
RecruitingNCT07699744Updated Sep 29, 2026

Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery

A Phase 4 interventional study of Dexamethasone (IV) and Single-shot interscalene brachial plexus block in Pain, Postoperative, Rebound Pain and Shoulder Injuries, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Sep 29, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓

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Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
19 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 148 studies testing dexamethasone in Pain, Postoperative — 27 open to participants now, 30 under way, 2 of them phase 3. Dexamethasone · Pain, Postoperative.

Planned enrollment
61st of 148
92 · median 89
Started
2026
with 16 others
Phase 4
75 of 148
14 open now
Primary completion
2027-06
later than 22 of 29 live
Registered
140th of 148
by date

Among the 148 studies testing dexamethasone in Pain, Postoperative, this one is the 61st largest by planned enrollment, is one of 17 that started in 2026, is one of 75 in phase 4, reaches primary completion later than 22 of the 29 other live ones, and was the 140th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

27 of the 148 studies testing dexamethasone in Pain, Postoperative are open now, in 8 countries. Recruiting first, the newest first:

21 more — sign in →

By country, each count listing its studies:

All 27 open studies →

About dexamethasone

Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 19 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 148 studies testing dexamethasone in Pain, Postoperative, or all of them as a file.
02

Study summary

Shoulder surgery often causes severe pain after the operation. To control this pain, doctors commonly perform a nerve block (interscalene brachial plexus block), which numbs the shoulder area. However, when the effect of a single-injection nerve block wears off, many patients experience sudden, intense pain known as "rebound pain".

One way to prevent rebound pain is to place a thin catheter near the nerves so that local anesthetic can be given continuously for a longer period (continuous nerve block). However, this method is technically demanding and can cause problems such as catheter dislodgement, infection, and inconvenience for patients. Another simpler option is to give a single-injection nerve block together with an intravenous (IV) injection of dexamethasone, a steroid medication known to prolong the effect of nerve blocks and reduce rebound pain.

The purpose of this study is to determine whether a single-injection nerve block combined with IV dexamethasone (5 mg) is not inferior to a continuous nerve block in preventing rebound pain after shoulder surgery. A total of 92 adult patients scheduled for elective shoulder surgery will be randomly assigned to one of the two groups. The main outcome is the rebound pain score, defined as the difference between the last pain score recorded in the recovery room (while the nerve block is still working) and the highest pain score reported within the first 24 hours after the nerve block. The investigators expect that the simpler single-injection method with IV dexamethasone will provide comparable pain control while avoiding the complications and inconvenience of catheter-based continuous nerve blocks.

03

Conditions studied

  • Pain, Postoperative
  • Rebound Pain
  • Shoulder Injuries
  • Rotator Cuff Injuries

Keywords

  • Rebound pain
  • Interscalene brachial plexus block
  • Single-shot nerve block
  • Continuous peripheral nerve block
  • Perineural catheter
  • Dexamethasone
  • Intravenous dexamethasone
  • Shoulder surgery
  • Rotator cuff repair
  • Regional anesthesia
  • Postoperative analgesia
  • Multimodal analgesia
  • Non-inferiority trial
  • Enhanced recovery after surgery
04

Who can participate

Ages eligible
19 Years to 79 Years
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

  • Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC)

Exclusion criteria

Exclusion Criteria:

  • Pre-existing neurological deficit of the brachial plexus
  • Emergency surgery
  • (ASA) physical status classification IV or higher
  • or history of to local anesthetics or dexamethasone
  • Severe pulmonary disease (e.g., )
  • (BMI) ≥ 35 kg/m²
  • Long-term use of
  • Long-term use of analgesics
  • Inability to cooperate or communicate
  • Pregnancy
Terms in these criteria, in plain language(6)

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Single-shot block with IV dexamethasone

    Participants receive a single-shot ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by intravenous dexamethasone 5 mg administered after confirmation of successful block on arrival in the operating room. Postoperatively, an intravenous patient-controlled analgesia (PCA) pump with fentanyl (10 mcg/mL, bolus 1 mL, lockout 6 min, no basal rate) is connected. All participants receive standard multimodal analgesia (intravenous acetaminophen 1000 mg plus ibuprofen 300 mg every 8 hours).

    Drug: Dexamethasone (IV) · Procedure: Single-shot interscalene brachial plexus block

  • Active comparator
    Continuous interscalene brachial plexus block

    Participants receive an ultrasound-guided continuous interscalene brachial plexus block: 0.75% ropivacaine 15-20 mL is injected at the interscalene level, and a perineural catheter is placed with the tip adjacent to the superior trunk. Postoperatively, a nerve block PCA (0.2% ropivacaine, basal rate 5 mL/h, bolus 3 mL, lockout 30 min) is connected via the catheter. All participants receive the same standard multimodal analgesia as the experimental arm.

    Procedure: Continuous interscalene brachial plexus block

Interventions

  • Intravenous dexamethasone 5 mg, administered as a single dose after confirmation of adequate sensory and motor block on arrival in the operating room.

  • ProcedureSingle-shot interscalene brachial plexus block

    Ultrasound-guided single-shot interscalene brachial plexus block performed with a 50 mm needle. 0.75% ropivacaine 15-20 mL is injected at the interscalene level. No perineural catheter is placed.

  • ProcedureContinuous interscalene brachial plexus block

    Ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by placement of a perineural catheter adjacent to the superior trunk. Continuous postoperative analgesia is provided through the catheter using 0.2% ropivacaine (basal rate 5 mL/h, bolus 3 mL, lockout time 30 min) via a patient-controlled analgesia pump.

06

What researchers measure

Primary outcomes

  1. Rebound Pain Score (RPS)

    Difference between the last pain score recorded in the post-anesthesia care unit (PACU) while the nerve block is still effective and the highest pain score reported within the first 24 hours after the nerve block, measured on an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Higher scores indicate more severe rebound pain. Non-inferiority margin: 1.5.

    Time frame: Within 24 hours after the nerve block

Secondary outcomes

  1. Postoperative pain score (NRS)

    Pain intensity at rest and during movement, measured on an 11-point NRS (0 = no pain, 10 = worst pain imaginable).

    Time frame: 4, 8, 12, 24, and 48 hours after surgery

  2. Peak NRS pain score

    Highest pain score reported during each period, on an 11-point NRS.

    Time frame: 0-24 hours and 24-48 hours after surgery

  3. Incidence of severe rebound pain

    Proportion of participants experiencing rebound pain with NRS ≥ 7.

    Time frame: Within 24 hours after the nerve block

  4. Block duration

    Time from completion of the nerve block to the first onset of pain.

    Time frame: Up to 48 hours after the nerve block

  5. Time to first rescue analgesic

    Time from the end of surgery to the first administration of rescue analgesics.

    Time frame: Up to 48 hours after surgery

  6. Cumulative opioid consumption

    Cumulative opioid consumption converted to oral morphine equivalents (OME), including PCA use and rescue opioids.

    Time frame: 24 and 48 hours after surgery

  7. Block performance time

    Single-shot group: time from donning gloves to needle removal. Continuous group: time from donning gloves to completion of aseptic dressing.

    Time frame: During the block procedure (day of surgery)

  8. Block failure rate

    Proportion of participants with inadequate sensory/motor block on arrival in the operating room requiring rescue block.

    Time frame: From block completion to start of surgery (day of surgery)

  9. Rescue block administration

    Proportion of participants requiring an additional rescue block (0.75% ropivacaine 5-10 mL).

    Time frame: Day of surgery

  10. Intraoperative rescue analgesic use

    Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg).

    Time frame: During surgery

  11. Conversion to general anesthesia

    Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain.

    Time frame: During surgery

  12. Intraoperative sedative consumption

    Total dose of propofol administered for sedation during surgery.

    Time frame: During surgery

  13. Quality of Recovery-15 Korean version (QoR-15K) score

    Quality of recovery assessed using the QoR-15K questionnaire (score range 0-150; higher scores indicate better recovery).

    Time frame: Baseline (day before surgery) and 24 hours after surgery

  14. Incidence of postoperative nausea and vomiting (PONV)

    Proportion of participants experiencing PONV and requiring antiemetics.

    Time frame: 4, 8, 12, 24, and 48 hours after surgery

  15. Length of hospital stay

    Duration of hospitalization from surgery to discharge.

    Time frame: From surgery to discharge, up to 30 days

  16. Patient satisfaction

    Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied.

    Time frame: 48 hours after surgery

  17. Incidence of hemidiaphragmatic paralysis

    Proportion of participants with phrenic nerve palsy after the block.

    Time frame: Within 24 hours after the nerve block

  18. Postoperative blood glucose change

    Change in blood glucose level on postoperative day 1 compared with baseline.

    Time frame: Postoperative day 1

  19. Incidence of surgical and anesthetic complications

    Surgical complications (surgical site infection, delayed wound healing) and anesthesia-related complications (nerve injury, local anesthetic systemic toxicity, catheter-related problems such as dislodgement, leakage, or infection).

    Time frame: Up to 30 days after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because the informed consent obtained from participants does not include provisions for data sharing with third parties.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.

Of 532 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 9 months is below that.

Counting every sponsor, half of 542 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Aug 2026, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2026
First posted
Jul 13, 2026
StartActual
Aug 25, 2026was Jul 2026
Primary completionEst.
Jun 15, 2027
CompletionEst.
Jul 15, 2027
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
Seoul National University Hospital is now Recruiting
Sep 29, 2026
Start date
Jul 15, 2026→Aug 25, 2026 (actual)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Not yet recruiting→Recruiting
    Seoul National University Hospital is now Recruiting
    Start date Jul 15, 2026→Aug 25, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07699744
Responsible party
Hansol Kim, MD (Clinical Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 13, 2026
Start date
Aug 25, 2026
Primary completion
Jun 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Hansol Kim, M.D.
Contact
hansolfrkr@gmail.com
+82-2-2072-2467
Hwan Suk Jang, M.D.
Contact
j4n6h5@gmail.com
+82-2-2072-2467

Oversight

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

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Studies of the drug tested here: Dexamethasone

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