Exparel and Dexamethasone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal Bupivacaine with Bupivacaine, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Shoulder Arthroscopic Surgeries. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Power Couple of Regional Analgesia? A Prospective Randomized Controlled Trial Comparing Block Duration With Liposomal Bupivacaine and Dexamethasone
Overview
This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.
Interventions
- Drug Liposomal Bupivacaine with Bupivacaine
Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery. - Drug Dexamethasone
6 mg preservative-free dexamethasone
Primary outcome measures
- time until resolution of sensory block [Time frame: 0-10 days]
Secondary outcome measures (4)
- duration of motor blockade [Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively]
- pain scores (scale of 0-10) [Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively]
- opioid consumption (in oral morphine equivalents) [Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively]
- known side effects of interscalene blocks [Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Adults aged 18 to 80 years
- ASA physical status 1-3
- Undergoing primary shoulder surgery with interscalene nerve block
Exclusion criteria
- ASA 4 or 5
- Revision shoulder surgery
- Daily chronic opioid use (over 3 months of continuous opioid use)
- Inability to communicate pain scores or need for analgesia
- Infection at the site of block placement
- Age under 18 years old or greater than 80 years old
- Pregnant women (as determined by point-of-care serum bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- BMI > 40
- severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07614802 · PRO00119364