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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 24 hours after the nerve block |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score (NRS) | Pain intensity at rest and during movement, measured on an 11-point NRS (0 = no pain, 10 = worst pain imaginable). | 4, 8, 12, 24, and 48 hours after surgery |
| Peak NRS pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hansol Kim, M.D. | Contact | +82-2-2072-2467 | hansolfrkr@gmail.com | |
| Hwan Suk Jang, M.D. | Contact | +82-2-2072-2467 | j4n6h5@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
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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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.
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Due to the nature of the intervention (presence or absence of a perineural catheter), participants, care providers, and outcomes assessors are not masked. The statistician performing the analysis will remain blinded to group allocation until the analysis is completed.
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| 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. |
|
Highest pain score reported during each period, on an 11-point NRS.
| 0-24 hours and 24-48 hours after surgery |
| Incidence of severe rebound pain | Proportion of participants experiencing rebound pain with NRS ≥ 7. | Within 24 hours after the nerve block |
| Block duration | Time from completion of the nerve block to the first onset of pain. | 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. | Up to 48 hours after surgery |
| Cumulative opioid consumption | Cumulative opioid consumption converted to oral morphine equivalents (OME), including PCA use and rescue opioids. | 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. | 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. | 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). | Day of surgery |
| Intraoperative rescue analgesic use | Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg). | During surgery |
| Conversion to general anesthesia | Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain. | During surgery |
| Intraoperative sedative consumption | Total dose of propofol administered for sedation during surgery. | 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). | Baseline (day before surgery) and 24 hours after surgery |
| Incidence of postoperative nausea and vomiting (PONV) | Proportion of participants experiencing PONV and requiring antiemetics. | 4, 8, 12, 24, and 48 hours after surgery |
| Length of hospital stay | Duration of hospitalization from surgery to discharge. | From surgery to discharge, up to 30 days |
| Patient satisfaction | Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied. | 48 hours after surgery |
| Incidence of hemidiaphragmatic paralysis | Proportion of participants with phrenic nerve palsy after the block. | Within 24 hours after the nerve block |
| Postoperative blood glucose change | Change in blood glucose level on postoperative day 1 compared with baseline. | 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). | Up to 30 days after surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000070599 | Shoulder Injuries |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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