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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-79
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/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 block

    Procedure/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.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Single-shot block with IV dexamethasoneExperimental treatment 2 interventions
Group B: Continuous interscalene brachial plexus blockActive comparator 1 intervention

Trial outcomes

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

Other outcomes

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