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Clinical trial

Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

ID
Name
APP-18-01917
Description
The investigators will be comparing pain scores and opioid use in patients receiving interscalene peripheral blocks with plain bupivacaine versus those receiving liposomal bupivacaine. Liposomal bupivacaine is described as releasing local anesthetic up to 72 hours after its injection; therefore if liposomal bupivacaine can provide extended pain relief compared to plain bupivacaine, the investigators can consider using it as our primary local anesthetic. As secondary outcomes, the investigators will also be looking at difference in functional status and long-term differences between the two local anesthetics.
Trial arms
Trial start
2019-02-21
Estimated PCD
2023-01-11
Trial end
2023-06-06
Status
Completed
Phase
Early phase I
Treatment
Bupivacaine liposome
The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either liposomal bupivacaine prior to the patient receiving surgery.
Arms:
Liposomal bupivacaine
Other names:
peripheral nerve block
Bupivacaine Hydrochloride
The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either plain bupivacaine prior to the patient receiving surgery.
Arms:
Bupivacaine
Other names:
peripheral nerve block
Size
40
Primary endpoint
Average worst pain score with movement over 3 days
3 days post-operative
Eligibility criteria
Inclusion Criteria: * medically optimized patients that will undergo an elective surgery for arthroscopic shoulder surgery Exclusion Criteria: * under 18 years pregnant or breast-feeding, non-English speaking, have renal or hepatic dysfunction, history of chronic opioid use, receiving worker's compensation, smoker, receiving capsular release, respiratory compromise or BMI \< 18 or \> 35 or allergy to local anesthetics or opioids
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators plan to perform a double blinded randomized control study. Patients will be randomly assigned to either group A or group B. Patients in group A will receive a bolus injection with 20 mL of 0.5% bupivacaine. Group B will receive 10 mL of 133 mg of liposomal bupivacaine mixed with 10 mL 0.5% bupivacaine.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The participants and data collectors are unaware of which group the patient belongs to. The anesthesiologist performing the nerve block will not be blinded.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2024-04-15

1 organization

1 product

2 indications

Organization
University of Southern California
Product
Bupivacaine
Indication
Shoulder Pain
Indication
Postoperative Pain