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

NCT ID: NCT06601647

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Shoulder joint surgery is an orthopedic surgery recognized to cause severe postoperative pain. The pain after shoulder rotator cuff repair surgery is severer than other shoulder joint surgeries due to the inflammatory reaction of tendon repair. Severe pain will reduce the patient's shoulder range of motion and delay postoperative functional recovery, and the use of powerful analgesics for pain relief may also increase the chance of side effects related to opiate analgesics. Therefore, postoperative pain control has become an important clinical issue.

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 to perform brachial plexus block significantly extended the block duration, reduced postoperative pain, and reduced the use of opiate analgesics. Brachial plexus block with low-dose dexmedetomidine plus ropicavaine significantly prolonged analgesia by 4 hours (14 hours vs. 10 hours) compared to ropicavaine alone, and reduced the dose of opiate analgesias in the first 24 hours after surgery. Compared to ropicavaine only, low-dose dexamethasone plus ropivacaine effectively extended the analgesic duration by 8 hours (19.7 hours vs. 11.8 hours) and reduced the dose of opioid analgesics within 36 hours after surgery (6.5mg versus 2mg). Meanwhile, continuous administration of ropicavaine through a catheter for brachial plexus block can maintain effective analgesia. 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 adjuvants dexamethasone and dexmedetomidine combined with ropivacaine on postoperative pain control and functional recovery following arthroscopic rotator cuff repair surgery. Specifically, we will examine the effect of dexamethasone or dexmedetomidine alone, and in combination, on the duration of the analgesic effect of ropivacaine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ropivacaine

0.6% ropivacaine, control

Group Type ACTIVE_COMPARATOR

adjuvant type

Intervention Type PROCEDURE

ropivacaine combined with adjuvant

ropivacaine + dexamethasone

0.6% ropivacaine + 2mg dexamethasone

Group Type EXPERIMENTAL

adjuvant type

Intervention Type PROCEDURE

ropivacaine combined with adjuvant

ropivacaine + dexmedetomidine

0.6% ropivacaine + 025ug/kg dexmedetomidine

Group Type EXPERIMENTAL

adjuvant type

Intervention Type PROCEDURE

ropivacaine combined with adjuvant

ropivacaine + dexamethasone + dexmedetomidine

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

Group Type EXPERIMENTAL

adjuvant type

Intervention Type PROCEDURE

ropivacaine combined with adjuvant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adjuvant type

ropivacaine combined with adjuvant

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hsin-Yi Wang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hsin-Yi Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VGHTPE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hsin-Yi Wang, MD, PhD

Role: CONTACT

886-2-28757549

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-07-006C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.