Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2021
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
March 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedFebruary 21, 2021
February 1, 2021
5 months
February 17, 2021
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
the duration of analgesia
time from completion of TPVB operation to VAS more than 3
48 hours after surgery
Secondary Outcomes (3)
total sufentanil consumption
48 hours after surgery
VAS
1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
adverse effects
48 hours after surgery
Study Arms (3)
RS group
ACTIVE COMPARATOR20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone
RM group
ACTIVE COMPARATOR20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine
RSM group
EXPERIMENTAL20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)
Interventions
Ultrasound-guided multilevelTPVB is performed at the end of lobectomy
Eligibility Criteria
You may qualify if:
- ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.
You may not qualify if:
- Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dong zhang
Study Record Dates
First Submitted
February 17, 2021
First Posted
February 21, 2021
Study Start
March 20, 2021
Primary Completion
August 20, 2021
Study Completion
August 30, 2021
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share