NCT04250272

Brief Summary

A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 16, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 29, 2020

Last Update Submit

January 29, 2020

Conditions

AnalgesiaPostoperative PainLung Cancer

Outcome Measures

Primary Outcomes (5)

  • Postoperative pain: numeric rating scale

    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    at postanesthesia care unit (PACU)

  • Postoperative pain: numeric rating scale

    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    3 hours later operation

  • Postoperative pain: numeric rating scale

    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    6 hours later operation

  • Postoperative pain: numeric rating scale

    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    12 hours later operation

  • Postoperative pain: numeric rating scale

    Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)

    24 hours later operation

Secondary Outcomes (2)

  • Number of analgesics consumption

    through study completion, an average of 1 yea

  • Amount of analgesics consumption

    : through study completion, an average of 1 year

Study Arms (2)

Serratus Anterior Plane Block

EXPERIMENTAL

Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.

Procedure: Thoracoscopic lobectomy

Intercostal Nerve Block

ACTIVE COMPARATOR

Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.

Procedure: Thoracoscopic lobectomy

Interventions

Thoracoscopic lobectomyPROCEDURE

Thoracoscopic lobectomy was performed for lung cancer

Intercostal Nerve BlockSerratus Anterior Plane Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer
  • American Society of Anesthesiologists (ASA) I-III class
  • Video-assisted thoracoscopic lobectomy

You may not qualify if:

  • previous history of allergy to local anesthetics
  • psychological disorder
  • chronic analgesics or sedatives use
  • coagulopathy
  • The presence of systemic infection or local infection at injection site
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, 700-412, South Korea

RECRUITING

MeSH Terms

Conditions

AgnosiaPain, PostoperativeLung Neoplasms

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Saeyoung Kim

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimin Heo

CONTACT

+82-53-420-5430knuhmrc@knu.ac.kr

Saeyoung Kim

CONTACT

+82-53-420-5873saeyoungkim7@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

August 16, 2019

Primary Completion

January 31, 2020

Study Completion

February 29, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

KR(1)