Efficacy of Different Adjuvants With Ropivacaine in Brachial Plexus Block on Anthroscopic Rotator Cuff Repair

NCT06601647 | Not Yet Recruiting

• 1 other identifier: 2024-07-006C
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The pain after shoulder rotator cuff repair surgery is severe due to the inflammatory reaction of tendon repair. Severe pain will reduce the patient's shoulder range of motion and delay functional recovery. The use of powerful analgesics for pain relief may also increase the chance of opiate analgesic-related side effects. Brachial plexus block with local anesthetic is widely used for pain control at the acute stage after shoulder arthroscopic surgery, but the maintenance time is often limited. Ropivacaine is a local anesthetic commonly used for brachial plexus block, and its half-life time is 11.8 hours. Clinical studies showed that using ropivacaine plus adjuvants such as dexamethasone or dexmedetomidine for brachial plexus block significantly extended the block duration, reduced postoperative pain, and reduced the use of opiate analgesics. However, the safest and most effective combination of local anesthetics remains unresolved. This trial aims to evaluate and compare the effects of brachial plexus block using dexamethasone and dexmedetomidine combined with ropivacaine on postoperative pain control and functional recovery after arthroscopic rotator cuff repair surgery.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• postoperative pain evaluated by NRS

  pain level by Numeric rating scale( 11 points ranging from 0 to 10; higher scores mean a worse outcome)

  postoperative 1hr (hour), 6hrs, 12hrs, 18hrs, 24hrs, 36hrs, 48hr; 3days , 7days, 14days, 30days, 60days, 180days

Study Arms (4)

ropivacaine

ACTIVE COMPARATOR

0.6% ropivacaine, control

Procedure: adjuvant type

ropivacaine + dexamethasone

EXPERIMENTAL

0.6% ropivacaine + 2mg dexamethasone

Procedure: adjuvant type

ropivacaine + dexmedetomidine

EXPERIMENTAL

0.6% ropivacaine + 025ug/kg dexmedetomidine

Procedure: adjuvant type

ropivacaine + dexamethasone + dexmedetomidine

EXPERIMENTAL

0.6% ropivacaine + 2mg dexamethasone + 0.25/ug/kg dexmedetomidine

Procedure: adjuvant type

Interventions

adjuvant type PROCEDURE

ropivacaine combined with adjuvant

ropivacaine; ropivacaine + dexamethasone; ropivacaine + dexamethasone + dexmedetomidine; ropivacaine + dexmedetomidine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>=20 years
• scheduled to anthroscopic rotator cuff repair at VGH, Taipei

You may not qualify if:

• with central or peripheral neurological disease
• refuse to sign informed consent
• ASA score \>=4
• blood oxygen saturation concentration \<90% when without using oxygen
• emergent surgery
• unstable vital signs (ie, use of vasopressors or inotropes)
• nasal mucosa damage or a history of nasal or skull base surgery
• not suitable for regional anesthesia (ie, abnormal coagulation function, taking anticoagulants)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Study Officials

• Hsin-Yi Wang, MD, PhD

  VGHTPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Yi Wang, MD, PhD

CONTACT

886-2-28757549; hywang8@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-08

Locations

TW (1)