NCT05379816

Brief Summary

The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 24, 2022

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

May 15, 2022

Last Update Submit

May 17, 2022

Conditions

Post-thoracotomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain score

    difference of Numerical rating scale, before and after

    3 months

Secondary Outcomes (1)

  • Quantitative sensory test

    3 months

Study Arms (2)

conservative treatment

NO INTERVENTION

analgesics are used for PTPS

Interventional treatment

ACTIVE COMPARATOR

perineural injection

Procedure: 5% DW perineural injection

Interventions

5% DW perineural injectionPROCEDURE

5% DW perineural injection to intercostal nerve

Interventional treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTPS after single port VATS

You may not qualify if:

  • abnormal sensation
  • can not complete questionnaire
  • others cause of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National taiwan university cancer center

Taipei, 106, Taiwan

RECRUITING

Study Officials

  • Wen-ying Lin, Dr.

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-ying Lin, Dr.

CONTACT

0972652006ying434@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Conservative management indicates medication treatment. Interventional treatment indicate injection treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 18, 2022

Study Start

May 3, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 24, 2022

Record last verified: 2021-10

Locations

TW(1)