UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062826 |
|---|---|
| Receipt number | R000071913 |
| Scientific Title | Effects of Timing of Peripheral Nerve Block and Dexamethasone as an Adjuvant on Postoperative Analgesia after Thoracic Surgery |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/04 14:56:30 |
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Basic information
Public title
Effects of Paravertebral Block Timing and Dexamethasone as an Adjuvant on Postoperative Analgesia After Thoracoscopic Surgery: A Randomized Single-Blind 2x2 Factorial Trial
Acronym
PVB Timing-Dex Study
Scientific Title
Effects of Timing of Peripheral Nerve Block and Dexamethasone as an Adjuvant on Postoperative Analgesia after Thoracic Surgery
Scientific Title:Acronym
PVB Timing-Dex Trial
Region
| Japan |
Condition
Condition
Acute postoperative pain after thoracoscopic surgery for lung cancer, mediastinal tumors, and other thoracic diseases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine whether the addition of dexamethasone to ropivacaine for paravertebral block prolongs postoperative analgesia and reduces rebound pain in patients undergoing thoracoscopic surgery. The study also aims to compare the analgesic effects of paravertebral block performed before versus after surgery and to identify an optimal perioperative analgesic strategy for thoracic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Total dose of fentanyl administered via intravenous patient-controlled analgesia (iv-PCA) during the first 24 hours after surgery.
Time from the end of surgery to the first use of iv-PCA by the patient.
Key secondary outcomes
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS) on the day of surgery and in the morning, afternoon, and evening on postoperative days 1 and 2.
Japanese version of the Quality of Recovery-15 (QoR-15) score at 24 and 48 hours after surgery.
Incidence of postoperative nausea and vomiting during the first 48 hours after surgery.
Incidence of adverse events, including postoperative infection and postoperative bleeding.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Paravertebral block is performed before surgery using 30 mL of 0.3% ropivacaine without dexamethasone.
Interventions/Control_2
Paravertebral block is performed before surgery using 30 mL of 0.3% ropivacaine with 3.3 mg of dexamethasone.
Interventions/Control_3
Paravertebral block is performed after surgery using 30 mL of 0.3% ropivacaine with 3.3 mg of dexamethasone.
Interventions/Control_4
Paravertebral block is performed after surgery using 30 mL of 0.3% ropivacaine without dexamethasone.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 to 75 years undergoing unilateral thoracoscopic surgery at Gifu University Hospital.
Patients with American Society of Anesthesiologists Physical Status (ASA-PS) 1-3.
Patients who provide written informed consent to participate in the study.
Key exclusion criteria
Patients with severe coagulation abnormalities.
Patients with a body mass index of 35 kg/m2 or greater.
Patients with diabetes mellitus and a random blood glucose level of 200 mg/dL or greater, or an HbA1c level of 7.3% or greater.
Patients with chronic pain currently requiring treatment.
Patients already receiving opioid analgesic therapy.
Patients unable to complete the study questionnaires.
Patients with cognitive impairment.
Patients considered inappropriate for participation by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keishu |
| Middle name | |
| Last name | Hayashi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Gifu 501-1194, Japan
TEL
058-230-6404
hayashi.keishu.k4@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kamiya |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Gifu 501-1194, Japan
TEL
058-230-6404
Homepage URL
kamiya.yoshinori.p2@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Keishu Hayashi
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Review Committee, Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, Gifu 501-1194, Japan
Tel
058-230-6059
rinri@t.gifu-u.ac.jp
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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071913
