UMIN-CTR Clinical Trial

Public title

Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery

Acronym

Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery

Scientific Title

Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery

Scientific Title:Acronym

Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery

Region

Japan

Condition

postoperative pain after shoulder surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study was to investigate the effect of programmed intermittent bolus(PIB) infusion on the occurrence of phrenic paralysis and postoperative analgesia in patients having ISB after shoulder surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Frequency of occurrence of phrenic paralysis at 1POD morning

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Patients who underwent scheduled shoulder surgery were randomly allocated to have continuous ISB at constant rate (Group C) or programmed intermittent bolus ISB (Group P).Prior to induction of general anesthesia, ISB was performed with 10 ml of 0.25% levobupivacaine under ultrasound guidance, then the catheter was indwelled.For intraoperative anesthesia management, propofol, desflurane, fentanyl, remifentanil, rocuronium were used. After the emergence from general anesthesia, 0.15% levobupivacaine was started at a constant rate of 5 ml/h in group C. Ambulatory PCA pump (CADD- Legacy, Smiths Medical, Minneapolis, USA) was used for the administration of levobupivacaine.

Interventions/Control_2

In group P, 10 ml of 0.15% levobupivacaine was administered as a bolus every 8 hours from the initial bolus.

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

Patients who undergo shoulder arthroplasty surgery can communicate without problems with cognitive function

Key exclusion criteria

>Patients who do not agree with this research
>Patients who have a history of allergic reaction to levobupivacaine
>Patients who are supposed to have problems with cognitive function when interrogating NRS
Patients presenting coagulopathy on examination
>Patients with a history of allergies to tramadol and opioids, patients with acute intoxication with alcohol, sleeping agents, analgesics, opioid analgesics or psychotropics
Epilepsy patients who are not adequately controlled by treatment
>Other patients judged unsuitable for the study by other doctors

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	TANAKA KUMIKO

Organization

Archi Medical University

Division name

Department of Anesthesiology

Zip code

Address

1-1 Karimata Yazako Nagakute city,Aichi,Japan

TEL

0561-62-3311

Email

tanaka.kumiko.776@mail.aichi-med-u.ac.jp

Name of contact person

1st name
Middle name
Last name	TANAKA KUMIKO

Organization

Archie Medical University Hospital

Division name

Department of Anesthesiology

Zip code

Address

1-1 Karimata Yazako Nagakute city,Aichi,Japan

TEL

0561-62-3311

Homepage URL

Email

tanaka.kumiko.776@mail.aichi-med-u.ac.jp

Institute

Archi Medical University Hospital

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

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

29

Day

Last modified on

2017

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034457