NCT04309630

Brief Summary

Thoracotomy is associated with severe postoperative pain due to surgical incision, rib retraction or resection, and intercostal nerve damage. Pain management after thoracic surgery is extremely important for various reasons, including respiratory mechanics, decreased atelectasis, early mobilization, decreased opioid consumption, decreased hospital stay, and patient satisfaction. Thoracic epidural analgesia and thoracic paravertebral blocks, although it comes to mind in the first place for thoracic surgery, the difficulty / failure of the application technique and the use of side effects such as spinal cord injury, pneumothorax and hypotension. Alternative regional methods have come to the fore in recent years. Erector spina plan block (ESPB) is a recently defined interfacial plan block used for the treatment of thoracic neuropathic pain, trauma and acute pain after surgery. Local anesthetic injection for ESPB can be applied both to the surface and deep into the erector spina muscle. When local anesthetic is applied deep into the erectral spina muscle, it has been demonstrated by the cadaver findings that the thoracic spinal nerves reach both the dorsal and ventral ramus with the spread of the paravertebral and intercostal areas. The thoracolumbar extension of the erector spina muscle allows wide cranio-caudal spread of injections in this plane and analgesia involving multiple dermatomes. This multisegmental analgesia allows ESPB to be used in pain management after thoracic or abdominal surgery. Accompanied by ultrasound, ESPB is simple and reliable. With the easy recognition of sonoanatomy, the risk of damage to the surrounding tissues is negligible . If necessary, a permanent catheter can be placed that can be used to prolong analgesia time and can be used for both intraoperative and postoperative analgesia with catheter-mediated ESPB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

March 12, 2020

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • analgesia

    postoperative analgesia assesment with visual analog score

    48 hours

Secondary Outcomes (2)

  • analgesia

    3 months

  • analgesia

    6 months

Study Arms (2)

intercostal block

ACTIVE COMPARATOR

patients received intercostal block will be evaluated by visual analog score for pain assesment

Procedure: intercostal block

erector spina plane block

EXPERIMENTAL

patients received erector spina plane block will be evaluated by visual analog score for pain assesment

Procedure: erector spina plane block

Interventions

pain control by intercostal block

intercostal block

pain control by erector spina plane block

erector spina plane block

Eligibility Criteria

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

You may qualify if:

  • ASA I-II
  • Thoracotomy patients

You may not qualify if:

  • Body mass index over 35
  • A history of allergy to drugs to be used in the study
  • Chronic pain reliever use
  • Patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigdem Yildirim Guclu

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • CIGDEM Y YILDIRIMGUCLU

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASS. PROFFESSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

March 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations