Pain, Postoperative, Rebound Pain, Shoulder Injuries, Rotator Cuff Injuries
Conditions
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
Brief 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.
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.
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebound Pain Score (RPS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score (NRS) | 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). |
| Peak NRS pain score | 0-24 hours and 24-48 hours after surgery | Highest pain score reported during each period, on an 11-point NRS. |
| Incidence of severe rebound pain | Within 24 hours after the nerve block | Proportion of participants experiencing rebound pain with NRS ≥ 7. |
| Block duration | Up to 48 hours after the nerve block | Time from completion of the nerve block to the first onset of pain. |
| Time to first rescue analgesic | Up to 48 hours after surgery | Time from the end of surgery to the first administration of rescue analgesics. |
| Cumulative opioid consumption | 24 and 48 hours after surgery | Cumulative opioid consumption converted to oral morphine equivalents (OME), including PCA use and rescue opioids. |
| Block performance time | 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. |
| Block failure rate | 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. |
| Rescue block administration | Day of surgery | Proportion of participants requiring an additional rescue block (0.75% ropivacaine 5-10 mL). |
| Intraoperative rescue analgesic use | During surgery | Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg). |
| Conversion to general anesthesia | During surgery | Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain. |
| Intraoperative sedative consumption | During surgery | Total dose of propofol administered for sedation during surgery. |
| Quality of Recovery-15 Korean version (QoR-15K) score | 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). |
| Incidence of postoperative nausea and vomiting (PONV) | 4, 8, 12, 24, and 48 hours after surgery | Proportion of participants experiencing PONV and requiring antiemetics. |
| Length of hospital stay | From surgery to discharge, up to 30 days | Duration of hospitalization from surgery to discharge. |
| Patient satisfaction | 48 hours after surgery | Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied. |
| Incidence of hemidiaphragmatic paralysis | Within 24 hours after the nerve block | Proportion of participants with phrenic nerve palsy after the block. |
| Postoperative blood glucose change | Postoperative day 1 | Change in blood glucose level on postoperative day 1 compared with baseline. |
| Incidence of surgical and anesthetic complications | 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). |
Countries
South Korea
Contacts
CONTACTHansol Kim, M.D.
CONTACTHwan Suk Jang, M.D.
Outcome results
None listed