UMIN-ICDS Clinical Trial

Public title

A study comparing anesthesia methods to reduce pain after arthroscopic rotator cuff repair: single-shot vs 7-day continuous interscalene block

Acronym

ARCR-ISB Trial

Scientific Title

Evaluation of the analgesic effects of single-shot versus continuous interscalene block in rotator cuff tear surgery

Scientific Title:Acronym

ARCR-ISB Trial

Region

Japan

Condition

Rotator cuff tear

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the analgesic effects of a preoperative single-shot interscalene brachial plexus block versus a preoperative continuous interscalene block with perineural catheter analgesia (maintained until POD7) in patients undergoing arthroscopic rotator cuff repair, focusing on the postoperative pain trajectory (NRS) and rescue analgesic consumption. We additionally aim to evaluate the time course of the analgesic benefit to determine how long the between-group difference in pain persists postoperatively.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postoperative pain intensity (NRS) longitudinal profile.
Time points: POD1, POD2, POD3, POD4, POD5, POD7.
NRS scores at each time point will be used to compare between-group differences in pain trajectory (group x time) between the single-shot and continuous interscalene block groups.
Time frame: POD1-POD7.

Key secondary outcomes

1.Rescue analgesic use (total count). Time frame: POD0, POD1, and cumulative POD0-1 (0-48 hours).

2.Early postoperative pain trajectory (NRS) until postoperative day 1.

3.Time to pain exacerbation after the block.

4.Postoperative dietary intake (%). Time frame: POD1-POD3, recorded for breakfast, lunch, and dinner.

5.Shoulder range of motion (ROM). Time frame: preoperative, 3 months, 6 months, 12 months. Measures: forward flexion, external rotation, and internal rotation (spinal level).

6.Shoulder strength. Time frame: preoperative, 6 months, 12 months. Measures: abduction strength at 45deg and 90deg, external rotation strength, and internal rotation strength.

7.Constant-Murley Score. Time frame: preoperative, 12 months.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Continuous group (catheter)

Preoperative ultrasound-guided interscalene brachial plexus block with perineural catheter placement. Initial bolus via catheter: ropivacaine 0.375% 10 mL plus dexamethasone sodium phosphate 3.3 mg. Postoperative continuous infusion: ropivacaine 0.2% at 4 mL/h until catheter removal. A 3 mL flush bolus via catheter is allowed for breakthrough pain. Planned catheter removal is POD7; early removal is allowed for adverse events or patient request.

Interventions/Control_2

Single-shot group (control)

Preoperative ultrasound-guided single-shot interscalene brachial plexus block at the same timing as the continuous group. Single bolus: ropivacaine 0.375% 10 mL plus dexamethasone sodium phosphate 3.3 mg.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients scheduled to undergo arthroscopic rotator cuff repair for rotator cuff tear

2.Eligible to receive a preoperative interscalene brachial plexus block (single-shot or continuous catheter technique)

3.Able to provide written informed consent

4.Age 20 years or older

Key exclusion criteria

1.Allergy, hypersensitivity, or contraindication to ropivacaine or dexamethasone (or local anesthetics)

2.Not suitable for interscalene block (e.g., infection at puncture site, significant coagulation abnormality)

3.Unable to provide reliable pain assessment (NRS) or informed consent due to severe cognitive impairment or psychiatric disorder

4.Revision surgery or concomitant major procedures

5.Severe pulmonary disease where the risk of phrenic nerve palsy is unacceptable

6.Any other condition judged by the investigator to make the patient unsuitable for study participation

Target sample size

90

Name of lead principal investigator

1st name	Ryuta
Middle name
Last name	Oishi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

990-9585

Address

2-2-2 Iida-nishi, Yamagata, Yamagata, Japan

TEL

08055725573

Email

buntcraftsman4@gmail.com

Name of contact person

1st name	Ryuta
Middle name
Last name	Oishi

Organization

Yoshioka Hospital

Division name

Department of Orthopaedic Surgery

Zip code

994-0026

Address

3-5-1 Hogashihoncho, Tendo, Yamagata, Japan

TEL

08055725573

Homepage URL

Email

buntcraftsman4@gmail.com

Institute

Yamagata University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yoshioka Hospital

Address

3-5-1 Hogashihoncho, Tendo, Yamagata, Japan

Tel

0236541188

Email

buntcraftsman4@gmail.com

Secondary IDs

YES

Study ID_1

YHTIB-2019-018

Org. issuing International ID_1

Yoshioka Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

吉岡病院（山形県）

Date of disclosure of the study information

2026

Year

03

Month

12

Day

URL releasing protocol

https://osf.io/75xrq/overview

Publication of results

Published

URL related to results and publications

https://osf.io/75xrq/overview

Number of participants that the trial has enrolled

86

Results

86 patients were randomized (SIB n=41, CIB n=45). CIB showed significantly lower daytime NRS on POD1 (difference -2.74, p<0.001), POD2 (-0.79, p=0.043), and POD3 (-0.79, p=0.043), with no differences thereafter. CIB required fewer rescue analgesics (IRR 2.09, p=0.008) and had longer time to pain rebound (30.0 h vs 15.5 h, p<0.001). No differences in 12-month functional or structural outcomes.

Results date posted

2026

Year

03

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Baseline characteristics of the 86 randomized patients were as follows. SIB group (n = 41): mean age 65.1 +/- 10.4 years; female 22 (53.7%); dominant-side surgery 32 (78.0%); Cofield classification: partial 4, medium 17, large 20. CIB group (n = 45): mean age 63.7 +/- 10.2 years; female 22 (50.0%); dominant-side surgery 36 (80.0%); Cofield classification: partial 5, medium 19, large 21. No significant differences were observed between groups in age, sex, proportion of dominant-side surgery, or Cofield classification.

Participant flow

All 86 patients who underwent ARCR during the study period were randomized by a sealed lot method: 41 to the SIB group and 45 to the CIB group. For the primary outcome analysis of daytime NRS, one patient in the CIB group was excluded due to delirium on POD0, yielding 41 patients in the SIB group and 44 in the CIB group. Twelve-month functional outcomes were available for 36 patients in the SIB group and 40 in the CIB group.

Adverse events

No serious adverse events were observed in either group. Catheter-related adverse events in the CIB group included early catheter removal in two patients (POD4: one patient requested removal; POD6: one accidental dislodgement). No catheter site infection or local anesthetic leakage was observed. No respiratory complications attributable to phrenic nerve palsy, local anesthetic systemic toxicity, or neurological complications were observed in either group.

Outcome measures

Primary outcome
Daytime maximum Numeric Rating Scale (NRS) pain score (09:00-21:00) on postoperative days (POD) 1, 2, 3, 4, 5, and 7, assessed at 21:00 each day. Between-group differences were estimated using a mixed-effects repeated-measures model (MMRM) with Holm adjustment for multiplicity.

Secondary outcomes
(1) Rescue analgesic count (POD0, POD1, and POD0-1 cumulative); (2) early pain trajectory at 2-hour intervals from 0 to 18 hours postoperatively; (3) time to pain rebound after block resolution; (4) rate of oral analgesic initiation on POD1; (5) dietary intake on POD1-3 (expressed as percentage of full meal); (6) shoulder range of motion (flexion, external rotation, internal rotation) at 3 and 12 months postoperatively; (7) shoulder muscle strength (abduction at 90 degrees, abduction at 45 degrees, external rotation, internal rotation) at 12 months postoperatively; (8) Constant-Murley score at 12 months postoperatively; (9) Sugaya classification on MRI at 12 months postoperatively.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

11

Month

25

Day

Date of IRB

2019

Year

11

Month

25

Day

Anticipated trial start date

2019

Year

12

Month

01

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

03

Month

12

Day

Last modified on

2026

Year

03

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069424