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NCT Number: NCT07699744

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rebound Pain Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • Long-term use of steroids
  • Long-term use of analgesics
  • Inability to cooperate or communicate
  • Pregnancy

Treatment and study plan

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 block

Procedure

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 block

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative pain score (NRS)

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

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

  2. Peak NRS pain score

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

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

  3. Incidence of severe rebound pain

    Time frame: Within 24 hours after the nerve block

    Proportion of participants experiencing rebound pain with NRS ≥ 7.

  4. Block duration

    Time frame: Up to 48 hours after the nerve block

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

  5. Time to first rescue analgesic

    Time frame: Up to 48 hours after surgery

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

  6. Cumulative opioid consumption

    Time frame: 24 and 48 hours after surgery

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

  7. Block performance time

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

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

  8. Block failure rate

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

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

  9. Rescue block administration

    Time frame: Day of surgery

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

  10. Intraoperative rescue analgesic use

    Time frame: During surgery

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

  11. Conversion to general anesthesia

    Time frame: During surgery

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

  12. Intraoperative sedative consumption

    Time frame: During surgery

    Total dose of propofol administered for sedation during surgery.

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

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

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

  14. Incidence of postoperative nausea and vomiting (PONV)

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

    Proportion of participants experiencing PONV and requiring antiemetics.

  15. Length of hospital stay

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

    Duration of hospitalization from surgery to discharge.

  16. Patient satisfaction

    Time frame: 48 hours after surgery

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

  17. Incidence of hemidiaphragmatic paralysis

    Time frame: Within 24 hours after the nerve block

    Proportion of participants with phrenic nerve palsy after the block.

  18. Postoperative blood glucose change

    Time frame: Postoperative day 1

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

  19. Incidence of surgical and anesthetic complications

    Time frame: Up to 30 days after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hansol Kim, M.D.

CONTACT

[email protected]

+82-2-2072-2467

Hwan Suk Jang, M.D.

CONTACT

[email protected]

+82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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