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Efficacy of Liposome Bupivacaine Combined with Bupivacaine vs Cocktail after Arthroscopic Rotator Cuff Repair Surgery

Efficacy of Liposome Bupivacaine Combined with Bupivacaine vs Cocktail after Arthroscopic Rotator Cuff Repair Surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106659
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder rotator cuff injury.

Interventions

Observation Group 1 (Control Group):The patient did not receive local infiltrative anesthesia for pain relief.
Observation Group 2 (Bupivacaine Liposome Group):The patient received local infiltrative anesthesia for pain relief using bupivacaine liposomes.
Observation Group 3 ("Cocktail" Group):The patient received local infiltrative anesthesia for pain relief using a "cocktail" approach.

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged >= 18 years old. 2. Diagnosed with a full-thickness rotator cuff tear and undergoing unilateral arthroscopic rotator cuff repair using a double-row fixation technique under general anesthesia. 3. Classified as American Society of Anesthesiologists (ASA) physical status grade I-III, possessing a certain level of education, with a good understanding of the Chinese language (both spoken and written), capable of unimpeded communication with medical staff, able to properly comprehend the Visual Analog Scale (VAS) for pain assessment, and willing to actively cooperate with relevant examinations. 4. The patient voluntarily participates in this trial, signs the informed consent form personally, and cooperates in completing all study evaluations.

Exclusion criteria

Exclusion criteria: 1. Allergy or intolerance to local anesthetics; 2. Recent use of narcotic analgesics for more than three weeks; 3. Presence of neuromuscular diseases in the operative limb; patients with other comorbidities that may affect postoperative rehabilitation; 4. Patients who have received treatment for coronary artery disease, vascular stent placement, deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past six months; 5. Presence of severe hepatic or renal dysfunction, coagulopathy, arrhythmia, infection, or other surgical contraindications; 6. Patients with any neurological or psychiatric disorders that may affect postoperative pain or interfere with study evaluations; 7. Patients with a history of abuse, misuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.

Design outcomes

Primary

MeasureTime frame
The Visual Analog Scale (VAS) was applied to compare the mean VAS scores at rest between the two groups at 24, 48, and 72 hours postoperatively.;

Secondary

MeasureTime frame
The mean Visual Analog Scale (VAS) scores during activity at 6, 24, 48, and 72 hours postoperatively.;VAS scores during both activity and rest at each postoperative time point (6, 24, 48, and 72 hours after surgery;The shoulder abduction angles of patients at 24, 48, and 72 hours postoperatively.;The sleep conditions of patients in the three days following surgery.;QoR-15 score at 72 hours postoperatively.;SPASDI score at 72 hours postoperatively.;The time when the patient first received analgesics after surgery.;

Countries

China

Contacts

Public ContactLi Yi

Department of Joint Surgery and Sports Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, 250000, China

liyivincent@126.com+86 151 6888 6286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026