Analgesia, Patient-ControlledNCT05691101
Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair
A study testing CISB with IV PCA group and CISB group in people with Analgesia, Patient-Controlled and Brachial Plexus Block, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Analgesia, Patient-Controlled, Brachial Plexus Block, Arthroscopic Rotator Cuff Repair
- What is being tested?
- CISB with IV PCA group and CISB group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2023to 31 Dec 2023
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having arthroscopic rotator cuff repair
- American Society of Anesthesiologists physical status I-III
Who cannot join
- Contraindication to interscalene brachial plexus block
- Contraindication to fentanyl
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national univercity Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Ji In Park, monica0120120@gmail.com
About this study
Official title: Comparison of Quality of Recovery in Patients Using Continuous Brachial Plexus Block With or Without Intravenous Patient-Controlled Analgesia After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study
The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.
Read the detailed description
The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers.
This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block.
This is expected to contribute to the patient satisfaction and quality of recovery.
- Being tested
- CISB with IV PCA group, CISB group
- Keywords
- Postoperative pain, IV PCA, Continuous interscalene brachial plexus block
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CISB with IV PCA groupOther
Ultrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter.
0.2 % ropivacaine 4 ml/hour was injected through the continuous brachial plexus block catheter. IV-PCA with fentanyl (basal flow 0 ml with patient selected bolus 14 mcg, lockout 10 minutes) was started.
CISB groupOther
Ultrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter.
0.2 % ropivacaine (4 ml/hour with patient selected bolus 5 ml, lockout 60 minutes) was injected through the continuous brachial plexus block catheter.
| Study group | Role | What they receive |
|---|---|---|
| Continuous interscalene brachial plexus block(CISB) with IV PCA group | Experimental | Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA Receives: Other: CISB with IV PCA group |
| Continuous interscalene brachial plexus block (CISB) group | Active comparator | Patients in this group received continuous interscalene brachial plexus block (CISB) Receives: Other: CISB group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)
Patient recovery measured by QoR-15K score
Measured: Postoperative 24 hour
Secondary outcomes (3)
Pain score
Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain)
Measured: Postoperative 6, 24, 48 hour
Cumulative consumption of PCA and rescue analgesics
Cumulative consumption of systemic analgesics
Measured: Postoperative 24, 48 hour
Occurrence of adverse effects
Nausea, vomiting, numbness, tingling sense, motor and sensory blockade
Measured: Postoperative 24, 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start31 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji In Park, Seoul National University Bundang Hospital
- Investigators
- JI IN PARK, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691101
- Sponsor's protocol ID
- B-2210/789-001
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Recovery in Patients Using Continuous Brachial Plexus Block With or Without Intravenous Patient-Controlled Analgesia After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05691101
- Acronym / sponsor ID
- B-2210/789-001
- Keywords
- Postoperative pain, IV PCA, Continuous interscalene brachial plexus block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Jan 2023 (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 goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.
Detailed description
The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers.
This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block.
This is expected to contribute to the patient satisfaction and quality of recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous interscalene brachial plexus block(CISB) with IV PCA group | Experimental | Other: CISB with IV PCA groupPatients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA |
| Continuous interscalene brachial plexus block (CISB) group | Active comparator | Other: CISB groupPatients in this group received continuous interscalene brachial plexus block (CISB) |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having arthroscopic rotator cuff repair
- American Society of Anesthesiologists physical status I-III
Key exclusion criteria (2 listed)
- Contraindication to interscalene brachial plexus block
- Contraindication to fentanyl
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 |
|---|---|---|
| CISB with IV PCA groupUltrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter. 0.2 % ropivacaine 4 ml/hour was injected through the continuous brachial plexus block catheter. IV-PCA with fentanyl (basal flow 0 ml with patient selected bolus 14 mcg, lockout 10 minutes) was started. | Other | Continuous interscalene brachial plexus block(CISB) with IV PCA group |
| CISB groupUltrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter. 0.2 % ropivacaine (4 ml/hour with patient selected bolus 5 ml, lockout 60 minutes) was injected through the continuous brachial plexus block catheter. | Other | Continuous interscalene brachial plexus block (CISB) group |
Primary outcome
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)
Time frame: Postoperative 24 hour
Patient recovery measured by QoR-15K score
3 secondary outcomes
Pain score
Time frame: Postoperative 6, 24, 48 hour
Cumulative consumption of PCA and rescue analgesics
Time frame: Postoperative 24, 48 hour
Occurrence of adverse effects
Time frame: Postoperative 24, 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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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.
JI IN PARK principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CISB with IV PCA group and CISB group in people with Analgesia, Patient-Controlled and Brachial Plexus Block, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 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 2 Feb 2023. 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 South Korea. 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 JI IN PARK (82 10 3077 3666, monica0120120@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery) (time frame: Postoperative 24 hour). 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 2 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.