AnesthesiaNCT06601647
Efficacy of Different Adjuvants With Ropivacaine in Brachial Plexus Block on Anthroscopic Rotator Cuff Repair
A study testing adjuvant type in people with Anesthesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- adjuvant type
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>=20 years
- scheduled to anthroscopic rotator cuff repair at VGH, Taipei
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blind Study: Effects of Different Adjuvants Combined With Ropivacaine in Interscalene Block on Postoperative Outcomes After Arthroscopic Rotator Cuff Repair
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.
Read the detailed description
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
- Anesthesia
- Being tested
- adjuvant type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant typeProcedure or surgery
ropivacaine combined with adjuvant
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Active comparator | 0.6% ropivacaine, control Receives: Procedure: adjuvant type |
| ropivacaine + dexamethasone | Experimental | 0.6% ropivacaine + 2mg dexamethasone Receives: Procedure: adjuvant type |
| ropivacaine + dexmedetomidine | Experimental | 0.6% ropivacaine + 025ug/kg dexmedetomidine Receives: Procedure: adjuvant type |
| ropivacaine + dexamethasone + dexmedetomidine | Experimental | 0.6% ropivacaine + 2mg dexamethasone + 0.25/ug/kg dexmedetomidine Receives: Procedure: adjuvant type |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain evaluated by NRS
pain level by Numeric rating scale( 11 points ranging from 0 to 10; higher scores mean a worse outcome)
Measured: postoperative 1hr (hour), 6hrs, 12hrs, 18hrs, 24hrs, 36hrs, 48hr; 3days , 7days, 14days, 30days, 60days, 180days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hsin-Yi Wang, Taipei Veterans General Hospital, Taiwan
- Investigators
- Hsin-Yi Wang, MD, PhD, Principal investigator, VGHTPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601647
- Sponsor's protocol ID
- 2024-07-006C
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Study: Effects of Different Adjuvants Combined With Ropivacaine in Interscalene Block on Postoperative Outcomes After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06601647
- Acronym / sponsor ID
- 2024-07-006C
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 19 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Active comparator | Procedure: adjuvant type0.6% ropivacaine, control |
| ropivacaine + dexamethasone | Experimental | Procedure: adjuvant type0.6% ropivacaine + 2mg dexamethasone |
| ropivacaine + dexmedetomidine | Experimental | Procedure: adjuvant type0.6% ropivacaine + 025ug/kg dexmedetomidine |
| ropivacaine + dexamethasone + dexmedetomidine | Experimental | Procedure: adjuvant type0.6% ropivacaine + 2mg dexamethasone + 0.25/ug/kg dexmedetomidine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age>=20 years
- scheduled to anthroscopic rotator cuff repair at VGH, Taipei
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvant typeropivacaine combined with adjuvant | Procedure or surgery | ropivacaine, ropivacaine + dexamethasone, ropivacaine + dexamethasone + dexmedetomidine, ropivacaine + dexmedetomidine |
Primary outcome
postoperative pain evaluated by NRS
Time frame: postoperative 1hr (hour), 6hrs, 12hrs, 18hrs, 24hrs, 36hrs, 48hr; 3days , 7days, 14days, 30days, 60days, 180days
pain level by Numeric rating scale( 11 points ranging from 0 to 10; higher scores mean a worse outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Yi Wang, MD, PhD principal investigator
VGHTPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjuvant type in people with Anesthesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Yi Wang, MD, PhD (886-2-28757549, hywang8@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain evaluated by NRS (time frame: postoperative 1hr (hour), 6hrs, 12hrs, 18hrs, 24hrs, 36hrs, 48hr; 3days , 7days, 14days, 30days, 60days, 180days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.