Pain, PostoperativePhase 4NCT07699744
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
A Phase 4 study testing Dexamethasone (IV), Single-shot interscalene brachial plexus block and Continuous interscalene brachial plexus block in people with Pain, Postoperative and Rebound Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Pain, Postoperative, Rebound Pain, Shoulder Injuries
- What is being tested?
- Dexamethasone (IV), Single-shot interscalene brachial plexus block and Continuous interscalene brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2026to 15 Jul 2027
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC)
Who cannot join
- Pre-existing neurological deficit of the brachial plexus
- Emergency surgery
- American Society of Anesthesiologists (ASA) physical status classification IV or higher
- Contraindication or history of hypersensitivity to local anesthetics or dexamethasone
- Severe pulmonary disease (e.g., chronic obstructive pulmonary disease)
- Body mass index (BMI) ≥ 35 kg/m²
Show all 10Show fewer
- Long-term use of steroids
- Long-term use of analgesics
- Inability to cooperate or communicate
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Hansol Kim, M.D., +82-2-2072-2467, hansolfrkr@gmail.com
Hwan Suk Jang, M.D., +82-2-2072-2467, j4n6h5@gmail.com
About this study
Official title: Pain Management Protocol Optimization for Rebound Pain Prevention and Enhanced Recovery After Shoulder Surgery: A Randomized Noninferiority Trial of Intravenous Dexamethasone Combined With Single-Shot Versus Continuous Brachial Plexus Block
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.
- Being tested
- Dexamethasone (IV), Single-shot interscalene brachial plexus block, Continuous interscalene brachial plexus block
- 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
- Medical subject headings
- Pain, Postoperative, Shoulder Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Intravenous dexamethasone 5 mg, administered as a single dose after confirmation of adequate sensory and motor block on arrival in the operating room.
Single-shot interscalene brachial plexus blockProcedure or surgery
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.
Continuous interscalene brachial plexus blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-shot block with IV dexamethasone | Experimental | 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). Receives: Drug: Dexamethasone (IV); Procedure: Single-shot interscalene brachial plexus block |
| Continuous interscalene brachial plexus block | Active comparator | 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. Receives: Procedure: Continuous interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after the nerve block
Secondary outcomes (19)
Postoperative pain score (NRS)
Pain intensity at rest and during movement, measured on an 11-point NRS (0 = no pain, 10 = worst pain imaginable).
Measured: 4, 8, 12, 24, and 48 hours after surgery
Peak NRS pain score
Highest pain score reported during each period, on an 11-point NRS.
Measured: 0-24 hours and 24-48 hours after surgery
Incidence of severe rebound pain
Proportion of participants experiencing rebound pain with NRS ≥ 7.
Measured: Within 24 hours after the nerve block
Block duration
Time from completion of the nerve block to the first onset of pain.
Measured: Up to 48 hours after the nerve block
Time to first rescue analgesic
Time from the end of surgery to the first administration of rescue analgesics.
Measured: Up to 48 hours after surgery
Cumulative opioid consumption
Cumulative opioid consumption converted to oral morphine equivalents (OME), including PCA use and rescue opioids.
Measured: 24 and 48 hours after surgery
Block performance time
Single-shot group: time from donning gloves to needle removal. Continuous group: time from donning gloves to completion of aseptic dressing.
Measured: During the block procedure (day of surgery)
Block failure rate
Proportion of participants with inadequate sensory/motor block on arrival in the operating room requiring rescue block.
Measured: From block completion to start of surgery (day of surgery)
Rescue block administration
Proportion of participants requiring an additional rescue block (0.75% ropivacaine 5-10 mL).
Measured: Day of surgery
Intraoperative rescue analgesic use
Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg).
Measured: During surgery
Conversion to general anesthesia
Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain.
Measured: During surgery
Intraoperative sedative consumption
Total dose of propofol administered for sedation during surgery.
Measured: During surgery
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).
Measured: Baseline (day before surgery) and 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Proportion of participants experiencing PONV and requiring antiemetics.
Measured: 4, 8, 12, 24, and 48 hours after surgery
Length of hospital stay
Duration of hospitalization from surgery to discharge.
Measured: From surgery to discharge, up to 30 days
Patient satisfaction
Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied.
Measured: 48 hours after surgery
Incidence of hemidiaphragmatic paralysis
Proportion of participants with phrenic nerve palsy after the block.
Measured: Within 24 hours after the nerve block
Postoperative blood glucose change
Change in blood glucose level on postoperative day 1 compared with baseline.
Measured: Postoperative day 1
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).
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start25 Aug 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Participants are randomly assigned in a 1:1 ratio to either single-shot interscalene brachial plexus block with intravenous dexamethasone 5 mg or continuous interscalene brachial plexus block. This is a non-inferiority trial.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hansol Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699744
- Sponsor's protocol ID
- 2605-154-1749
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management Protocol Optimization for Rebound Pain Prevention and Enhanced Recovery After Shoulder Surgery: A Randomized Noninferiority Trial of Intravenous Dexamethasone Combined With Single-Shot Versus Continuous Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT07699744
- Acronym / sponsor ID
- 2605-154-1749
- Keywords
- Rebound pain, Interscalene brachial plexus block, Single-shot nerve block, Continuous peripheral nerve block, Perineural catheter, Dexamethasone, Intravenous dexamethasone, Shoulder surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either single-shot interscalene brachial plexus block with intravenous dexamethasone 5 mg or continuous interscalene brachial plexus block. This is a non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Single-shot block with IV dexamethasone | Experimental | Drug: Dexamethasone (IV), Procedure: Single-shot interscalene brachial plexus blockParticipants 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). |
| Continuous interscalene brachial plexus block | Active comparator | Procedure: Continuous interscalene brachial plexus blockParticipants 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. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC)
Key exclusion criteria (10 listed)
- Pre-existing neurological deficit of the brachial plexus
- Emergency surgery
- American Society of Anesthesiologists (ASA) physical status classification IV or higher
- Contraindication or history of hypersensitivity to local anesthetics or dexamethasone
- Severe pulmonary disease (e.g., chronic obstructive pulmonary disease)
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 |
|---|---|---|
| Dexamethasone (IV)Intravenous dexamethasone 5 mg, administered as a single dose after confirmation of adequate sensory and motor block on arrival in the operating room. | Drug | Single-shot block with IV dexamethasone |
| Single-shot interscalene brachial plexus blockUltrasound-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. | Procedure or surgery | Single-shot block with IV dexamethasone |
| Continuous interscalene brachial plexus blockUltrasound-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. | Procedure or surgery | Continuous interscalene brachial plexus block |
Primary outcome
Rebound Pain Score (RPS)
Time frame: Within 24 hours after the nerve block
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.
19 secondary outcomes
Postoperative pain score (NRS)
Time frame: 4, 8, 12, 24, and 48 hours after surgery
Peak NRS pain score
Time frame: 0-24 hours and 24-48 hours after surgery
Incidence of severe rebound pain
Time frame: Within 24 hours after the nerve block
Block duration
Time frame: Up to 48 hours after the nerve block
Time to first rescue analgesic
Time frame: Up to 48 hours after surgery
Cumulative opioid consumption
Time frame: 24 and 48 hours after surgery
Block performance time
Time frame: During the block procedure (day of surgery)
Block failure rate
Time frame: From block completion to start of surgery (day of surgery)
Rescue block administration
Time frame: Day of surgery
Intraoperative rescue analgesic use
Time frame: During surgery
Conversion to general anesthesia
Time frame: During surgery
Intraoperative sedative consumption
Time frame: During surgery
Quality of Recovery-15 Korean version (QoR-15K) score
Time frame: Baseline (day before surgery) and 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 4, 8, 12, 24, and 48 hours after surgery
Length of hospital stay
Time frame: From surgery to discharge, up to 30 days
Patient satisfaction
Time frame: 48 hours after surgery
Incidence of hemidiaphragmatic paralysis
Time frame: Within 24 hours after the nerve block
Postoperative blood glucose change
Time frame: Postoperative day 1
Incidence of surgical and anesthetic complications
Time frame: Up to 30 days after surgery
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 29 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
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 Dexamethasone (IV), Single-shot interscalene brachial plexus block and Continuous interscalene brachial plexus block in people with Pain, Postoperative and Rebound Pain, run by Seoul National University Hospital at 1 site in South Korea.
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 10 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 29 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 South Korea. 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 Hansol Kim, M.D. (+82-2-2072-2467, hansolfrkr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebound Pain Score (RPS) (time frame: Within 24 hours after the nerve block). 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 29 Sep 2026.