NCT04191850

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 single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration 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

February 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.9 years

First QC Date

December 4, 2019

Last Update Submit

December 9, 2019

Conditions

AnalgesiaPostoperative PainPneumothorax

Outcome Measures

Primary Outcomes (4)

  • 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)

    After removal of chest tube

Secondary Outcomes (2)

  • Number of analgesics consumption

    through study completion, an average of 1 year

  • Amount of analgesics consumption

    through study completion, an average of 1 year

Study Arms (2)

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: Single Port Video-Assisted Thoracoscopic Surgery

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: Single Port Video-Assisted Thoracoscopic Surgery

Interventions

Single Port Video-Assisted Thoracoscopic SurgeryPROCEDURE

Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

Intercostal Nerve BlockSerratus Anterior Plane Block

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • primary spontaneous pneumothorax
  • elective single port video-assisted thoracoscopic wedge resection of the lung.

You may not qualify if:

  • secondary spontaneous pneumothorax
  • reoperation in ipsilateral thorax
  • a history of drug allergy for analgesics
  • participants who have difficulty understanding the study protocol
  • refusal of participants

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, PostoperativePneumothorax

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Saeyoung Saeyoung

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimin Heo

CONTACT

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

Saeyoung Saeyoung

CONTACT

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

Study Design

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

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 10, 2019

Study Start

February 1, 2018

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

KR(1)