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Determination of MEV90 of liposomal bupivacaine for Interscalene brachial plexus block for Postoperative Analgesia after rotator cuff repair by Biased Coin Design Sequential Method

Determination of MEV90 of liposomal bupivacaine for Interscalene brachial plexus block for Postoperative Analgesia after rotator cuff repair by Sequential Method

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085466
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-16
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Rotator cuff injury

Interventions

experimental group:The volume of bupivacaine liposome used by the first patient was 10ml according to clinical routine and previous studies. Then the concentration of local anesthetic for nerve block
If the previous patients effect is "successful" (positive reaction), the volume of local anesthetics used by this patient will be biased randomly, with a probability of 11%(b=0.11) decreasing by one u

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients undergoing arthroscopic rotator cuff repair in the First Affiliated Hospital of Zhengzhou University; (2) ASA?-?; (3) Age =18, =65 years old, gender is not limited; (4) BMI: 18-30kg/m2; (5) Patients were treated with nerve block and PCIA after operation.

Exclusion criteria

Exclusion criteria: (1) Accompanied by nerve injury or diseases around the shoulder joint, including thoracic outlet syndrome, multiple sclerosis, cervical intervertebral disc disease with ipsilateral radiculopathy, etc. (2) Accompanied by abnormal sensory or motor function of upper limbs; (3) There is active infection at the puncture site, or there is coagulation dysfunction (hemophilia, von Willebrand, or international normalized ratio INR > 2); (4) Severe respiratory diseases and a history of serious cardiovascular and cerebrovascular diseases; (5) Combined with diabetes or nervous system dysfunction; (6) Unable to understand or cooperate with VAS raters; (7) History of shoulder surgery; (8) Failed nerve block; (9) History of local anesthetic allergy in the past; (10) Long-term use of opioids (use time =3 months or use time =1 month and daily dose =5mg morphine equivalent); (11) Operation time 3h.

Design outcomes

Primary

MeasureTime frame
24-hour analgesic effect;

Secondary

MeasureTime frame
Pain intensity scores;postsurgical opioid consumption;time to first postsurgical opioid rescue medication;diaphragmatic excursion;spirometry;Satisfaction degree of analgesic treatment;Sleep quality;

Countries

China

Contacts

Public ContactWang Haitao

The First Affiliated Hospital of Zhengzhou University

wht1616@163.com+86 159 3719 5785

Outcome results

None listed

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