Postoperative Pain, Shoulder Arthroscopy
Conditions
Keywords
Diaphragm-sparing block, Postoperative analgesia, Regional anesthesia, Axillary nerve block, Suprascapular nerve block, Shoulder arthroscopy, Shoulder Posterior Pericapsular Nerve Group block, SPENG block
Brief summary
This prospective, randomized, patient- and assessor-blinded, single-center non-inferiority trial will compare the analgesic efficacy of the Shoulder Posterior Pericapsular Nerve Group (SPENG) block with combined posterior suprascapular and axillary nerve blocks in adults undergoing elective shoulder arthroscopy under general anesthesia. Both groups will receive the same total volume and concentration of local anesthetic. The primary outcome will be the highest resting Numeric Rating Scale pain score recorded during the first 24 postoperative hours. Secondary outcomes will include block performance time, sensory block success in suprascapular and axillary nerve territories, opioid consumption, time to rescue analgesia, motor function, diaphragmatic function, postoperative recovery quality, patient satisfaction, and block-related complications.
Interventions
PROCEDUREShoulder Posterior Pericapsular Nerve Group (SPENG) Block
An ultrasound-guided single-injection posterior pericapsular block. With the participant in the lateral decubitus position and the operative shoulder uppermost, a high-frequency linear ultrasound transducer will be placed transversely immediately inferior to the posterior acromion. After identification of the humeral head, articular cartilage, infraspinatus muscle, and posterior glenoid rim, a block needle will be advanced in-plane in a medial-to-lateral direction. The needle tip will be positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be injected.
PROCEDURECombined Posterior Suprascapular and Axillary Nerve Blocks
wo ultrasound-guided nerve blocks will be performed. For the posterior suprascapular nerve block, the suprascapular nerve will be identified in the suprascapular notch region beneath the supraspinatus muscle, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered. For the axillary nerve block, the posterior humeral circumflex artery will be identified using color Doppler in the quadrilateral space, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered adjacent to the axillary nerve.
Sponsors
Izmir City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to treatment allocation. Before block placement, participants will receive intravenous midazolam. Both groups will be positioned similarly, and identical dressings will be applied over the posterior shoulder and suprascapular regions after block completion to conceal the injection sites. Outcome assessments will be performed by an investigator who is not involved in block administration and is unaware of treatment allocation. The physician performing the block cannot be blinded because of the procedural differences between the interventions and will not participate in outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either a single-injection Shoulder Posterior Pericapsular Nerve Group (SPENG) block or combined posterior suprascapular and axillary nerve blocks before elective shoulder arthroscopy. Both groups will receive the same total volume, concentration, and dose of local anesthetic.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * American Society of Anesthesiologists (ASA) physical status I-III * Scheduled to undergo elective shoulder arthroscopy under general anesthesia * Able to understand the Numeric Rating Scale for pain assessment * Able and willing to provide written informed consent
Exclusion criteria
* Known allergy or hypersensitivity to local anesthetics used in the study * Infection at the planned block injection site * Coagulopathy or ongoing anticoagulant therapy that cannot be appropriately interrupted for peripheral nerve block * Pre-existing neurological deficit affecting the operative upper extremity * Moderate or severe pulmonary disease * Known diaphragmatic dysfunction * Chronic opioid use * Chronic pain syndrome * Body mass index greater than 35 kg/m² * Pregnancy or breastfeeding * Inability to understand or reliably report Numeric Rating Scale pain scores * Inadequate sonographic window preventing safe performance of the allocated block technique before randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours | From arrival in the post-anesthesia care unit through 24 hours after surgery | Resting postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). For each participant, the highest resting NRS score recorded during the first 24 postoperative hours will be used as the primary outcome. Scheduled assessments will be performed on arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery. Resting NRS scores obtained immediately before rescue analgesic administration outside these scheduled assessments will also be included when determining the highest value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Performance Time | Periprocedural | Time required to perform the allocated regional anesthesia technique, measured in seconds from the first contact of the ultrasound transducer with the skin until removal of the block needle after completion of local anesthetic injection. |
| Proportion of Participants With Complete Dual-Target Sensory Block Success | 30 minutes after block completion | Cold sensation will be assessed over the posterior shoulder (suprascapular nerve territory) and lateral deltoid region (axillary nerve territory) using a 3-point scale: 0 = absent sensation, 1 = reduced sensation, and 2 = normal sensation. Suprascapular sensory component success will be defined as a reduction of at least one grade from baseline in the posterior shoulder region. Axillary sensory component success will be defined as a reduction of at least one grade from baseline in the lateral deltoid region. Complete dual-target sensory block success will require successful sensory blockade in both territories in the same participant. |
| Cumulative Opioid Consumption During the First 24 Postoperative Hours | From arrival in the post-anesthesia care unit through 24 hours after surgery | All rescue opioid analgesics administered during the first 24 postoperative hours will be recorded and converted to intravenous morphine-equivalent dose for comparison between groups. |
| Time to First Rescue Analgesic | From block completion through 24 hours after surgery | Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain. |
| Resting Numeric Rating Scale Pain Scores | On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery | Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain). |
| Numeric Rating Scale Pain Scores With Movement | On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery | Pain intensity during standardized shoulder-related movement will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain), when clinically feasible. |
| Anterior Shoulder Numeric Rating Scale Pain Score | At 8, 12, and 24 hours after surgery | Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10. |
| Posterior Shoulder Numeric Rating Scale Pain Score | At 8, 12, and 24 hours after surgery | Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10. |
| Proportion of Participants With Hemidiaphragmatic Paresis | 30 minutes after block completion | Diaphragmatic excursion will be assessed using M-mode ultrasonography. Hemidiaphragmatic paresis will be defined as diaphragmatic excursion 30 minutes after block completion falling to less than 25% of the participant's baseline excursion. |
| Change in Diaphragmatic Excursion From Baseline | Baseline and 30 minutes after block completion | Diaphragmatic excursion will be measured using M-mode ultrasonography as the difference in diaphragm position between resting expiration and deep inspiration. Three measurements will be obtained and averaged. Change from baseline will be evaluated after the block. |
| Shoulder Abduction Motor Strength | Baseline, 30 minutes after block completion, and 24 hours after surgery | Shoulder abduction strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 to 5, with higher scores indicating greater muscle strength. |
| Proportion of Participants With Rebound Pain | During the first 24 postoperative hours | Rebound pain will be defined as an increase from an NRS pain score of 3 or lower at the preceding assessment to an NRS score of 7 or higher at the subsequent assessment. |
| Quality of Recovery-15 Score | 24 hours after surgery | Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery. |
| Patient Satisfaction With Perioperative Analgesia | 24 hours after surgery | Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied). |
| Number of Participants With Block-Related Complications | From block performance through postoperative day 7 | Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications. |
Contacts
CONTACTMurat KAYKAC, MD
PRINCIPAL_INVESTIGATORMurat KAYKAC, MD
Izmir City Hospital
STUDY_DIRECTORDerya ARSLAN YURTLU, Professor
Izmir City Hospital
Outcome results
None listed