Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy
Conditions
Keywords
shoulder arthroscopy, diaphragmatic dysfunction, respiratory function, liposomal bupivacaine
Brief summary
This study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial. It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
Detailed description
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
Interventions
DRUGOBV bupivacaine liposome group
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg. This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
DRUGStandard dose bupivacaine liposome group
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene
Sponsors
Affiliated Hospital of Jiaxing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older. * ASA classification I-III. * Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Exclusion criteria
* Have a history of lung disease. * Coagulation dysfunction or coagulopathy. * History of allergy to local anesthetics. * infection or lesions at the block site; or history of cervical spine disease. * pregnancy. * Refusal to participate in the study or inability to communicate. * Long-term use of opioids. * Body mass index \>35 kg/m2 * Previous history of nerve injury, paralysis, or paresis;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in numeric rating scale scores for resting pain at 24 hours after surgery | postoperative 24 hours | Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery. Postoperatively, the NRS scale was used to evaluate pain scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total consumption of morphine milligram equivalents within 72 hours postoperatively | within 72 hours postoperatively | Record opioid analgesics within 72 hours postoperatively, convert to morphine equivalent dose, and calculate the total amount. |
| Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively | postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours | Differences in numeric rating scale (0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively. Postoperatively, the NRS scoring scale was used to assess pain scores. |
| Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block | postoperative 0.5 hours, 6 hours and 24 hours | A diaphragm excursion of \>75% on the blocked side measured under ultrasound is defined as complete unilateral hemidiaphragmatic paralysis (HDP). |
| Pulmonary function | postoperative 0.5 hours, 6 hours and 24 hours | Use a portable respiratory function tester for bedside testing; have the patient blow three times and take the average. |
| All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively | within 72 hours postoperatively | Adverse events associated with nerve blocks within 72 hours postoperatively, including pneumothorax, intravascular injection, local anesthetic toxicity, and Horner syndrome, were recorded. |
| The number of rescue analgesic interventions required within 72 hours postoperatively | within 72 hours postoperatively | The number of analgesic administrations within the first 72 hours postoperatively was recorded. |
| sensorimotor score | postoperative 0.5 hours, 6 hours and 24 hours | After completion of the block, the simplified sensorimotor assessment scale (3-point method) is used for evaluation, and a total sensorimotor score ≥12 points with a total sensory score ≥3 points is defined as successful brachial plexus block. |
Countries
China
Outcome results
None listed