NCT05691101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 10, 2023

Last Update Submit

January 31, 2023

Conditions

Analgesia, Patient-ControlledBrachial Plexus BlockArthroscopic Rotator Cuff Repair

Keywords

Postoperative painIV PCAContinuous interscalene brachial plexus block

Outcome Measures

Primary Outcomes (1)

  • 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

    Postoperative 24 hour

Secondary Outcomes (3)

  • Pain score

    Postoperative 6, 24, 48 hour

  • Cumulative consumption of PCA and rescue analgesics

    Postoperative 24, 48 hour

  • Occurrence of adverse effects

    Postoperative 24, 48 hour

Study Arms (2)

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

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)

Other: CISB group

Interventions

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.

Continuous interscalene brachial plexus block(CISB) with IV PCA group
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.

Continuous interscalene brachial plexus block (CISB) group

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication to interscalene brachial plexus block
  • Contraindication to fentanyl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national univercity Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • JI IN PARK

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JI IN PARK

CONTACT

82 10 3077 3666monica0120120@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

January 31, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)