NCT06098859

Brief Summary

Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 13, 2023

Last Update Submit

October 23, 2023

Conditions

Pain, PostoperativeRespiratory Complication

Keywords

Thoracic epidural analgesiaerector spinae plane blockheart surgery

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain

    Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale). Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)….. 10: Unbearable pain (the worst)

    Postoperative 48 hours

  • Respiratory functions

    Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement. Tachypnea:more than 20/min Fever: more than 37 C celcius Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)

    Postoperative 48 hours

Secondary Outcomes (2)

  • Analgesic requirement. When the VRS was more than 4 points

    Postoperative 48 hours

  • Intensive care and hospital stay

    postoperative 30 days

Study Arms (3)

Thoracic epidural analgesia

ACTIVE COMPARATOR

Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours

Procedure: Thoracic epidural analgesia

Erector spinae plane block

ACTIVE COMPARATOR

Erector spinae plane blockwas applied preoperatively

Procedure: Erector spinae plane block

Intravenous opioid analgesia

NO INTERVENTION

Intravenous opioid analgesia was administered during the surgery

Interventions

Thoracic epidural analgesiaPROCEDURE

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Thoracic epidural analgesia
Erector spinae plane blockPROCEDURE

Erector spinae plane block was applied preoperatively using local anesthetic

Erector spinae plane block

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has ASA II-IV score
  • Having open heart surgery

You may not qualify if:

  • Having a psychiatric illness
  • Using analgesic medication due to chronic pain
  • Uncooperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Engin Ertürk

Ortahisar, Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Engin Ertürk, Prof. Dr

    Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 25, 2023

Study Start

January 10, 2023

Primary Completion

August 28, 2023

Study Completion

September 15, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
starting12 months after publication
Access Criteria
analyst and investigators

Locations

TU(1)