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Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691101
Enrollment
80
Registered
2023-01-19
Start date
2023-01-31
Completion date
2023-12-31
Last updated
2023-02-02

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

Conditions

Analgesia, Patient-Controlled, Arthroscopic Rotator Cuff Repair, Brachial Plexus Block

Keywords

Postoperative pain, IV PCA, Continuous interscalene brachial plexus block

Brief 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.

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.

Interventions

OTHERCISB with IV PCA group

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.

OTHERCISB group

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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Having arthroscopic rotator cuff repair * American Society of Anesthesiologists physical status I-III

Exclusion criteria

* Contraindication to interscalene brachial plexus block * Contraindication to fentanyl

Design outcomes

Primary

MeasureTime frameDescription
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)Postoperative 24 hourPatient recovery measured by QoR-15K score

Secondary

MeasureTime frameDescription
Pain scorePostoperative 6, 24, 48 hourNumerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain)
Cumulative consumption of PCA and rescue analgesicsPostoperative 24, 48 hourCumulative consumption of systemic analgesics
Occurrence of adverse effectsPostoperative 24, 48 hourNausea, vomiting, numbness, tingling sense, motor and sensory blockade

Countries

South Korea

Contacts

Primary ContactJI IN PARK
monica0120120@gmail.com82 10 3077 3666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026