NCT05083832

Brief Summary

Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery. In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

June 9, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

October 6, 2021

Last Update Submit

March 5, 2024

Conditions

Pain, PostoperativeThoracotomyErector Spinae Plane BlockSerratus Anterior Plane Block

Keywords

Pain, PostoperativeThoracotomyErector spinae plane blockSerratus anterior plane block

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th, 48th and 72nd hours after surgery.

    72 hours after surgery

Secondary Outcomes (2)

  • Morphine consumption

    24 hours after surgery

  • Side effects

    72 hours after surgery

Study Arms (2)

Continuous erector spinae plane block

ACTIVE COMPARATOR

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via erector spinae plane block catheter.

Procedure: Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block

Continuous serratus anterior plane block

ACTIVE COMPARATOR

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the serratus anterior muscles until the fourth rib area. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via serratus anterior plane block catheter.

Procedure: Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block

Interventions

Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane BlockPROCEDURE

Two different catheter techniques with same doses local anesthetic infusion

Continuous erector spinae plane blockContinuous serratus anterior plane block

Eligibility Criteria

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

You may qualify if:

  • to 65 years old
  • ASA physical status I-II-III
  • BMI 18 to 30 kg/m2
  • Elective thoracotomy surgery

You may not qualify if:

  • Patient refusing the procedure
  • Emergency surgery
  • History of chronic opioid or analgesic used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 19, 2021

Study Start

June 9, 2021

Primary Completion

January 9, 2024

Study Completion

February 20, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)