UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Title of the study (Brief title)	Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Region	Japan

Condition
Condition	postoperative pain after shoulder surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Frequency of occurrence of phrenic paralysis at 1POD morning
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	TANAKA KUMIKO
Organization	Archi Medical University
Division name	Department of Anesthesiology
Address	1-1 Karimata Yazako Nagakute city,Aichi,Japan
TEL	0561-62-3311
Email	tanaka.kumiko.776@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	TANAKA KUMIKO
Organization	Archie Medical University Hospital
Division name	Department of Anesthesiology
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

Sponsor
Institute	Archi Medical University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 29 Day
Last modified on	2017 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034457