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Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries

Primary Purpose

Pain, Postoperative, Respiratory Complication

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Thoracic epidural analgesia

Erector spinae plane block

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Thoracic epidural analgesia, erector spinae plane block, heart surgery

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Has ASA II-IV score Having open heart surgery Exclusion Criteria: Having a psychiatric illness Using analgesic medication due to chronic pain Uncooperative

Sites / Locations

Engin Ertürk

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Thoracic epidural analgesia

Erector spinae plane block

Intravenous opioid analgesia

Arm Description

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

Erector spinae plane blockwas applied preoperatively

Intravenous opioid analgesia was administered during the surgery

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Analgesic requirement. When the VRS was more than 4 points

diclofenac (75 mg), tramadol (50mg)

Intensive care and hospital stay

time for Intensive care and hospital (hours and days, respectively)

Full Information

NCT ID

NCT06098859

First Posted

October 13, 2023

Last Updated

October 23, 2023

Sponsor

Karadeniz Technical University

1. Study Identification

Unique Protocol Identification Number

NCT06098859

Brief Title

Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries

Official Title

Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 10, 2023 (Actual)

Primary Completion Date

August 28, 2023 (Actual)

Study Completion Date

September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

Detailed Description

Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours. Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia. The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day. All patients underwent general anesthesia with the same method and medications. Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Respiratory Complication

Keywords

Thoracic epidural analgesia, erector spinae plane block, heart surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.

Masking

ParticipantOutcomes Assessor

Masking Description

Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thoracic epidural analgesia

Arm Type

Active Comparator

Arm Description

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

Arm Title

Erector spinae plane block

Arm Type

Active Comparator

Arm Description

Erector spinae plane blockwas applied preoperatively

Arm Title

Intravenous opioid analgesia

Arm Type

No Intervention

Arm Description

Intravenous opioid analgesia was administered during the surgery

Intervention Type

Procedure

Intervention Name(s)

Thoracic epidural analgesia

Intervention Description

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane block

Intervention Description

Erector spinae plane block was applied preoperatively using local anesthetic

Primary Outcome Measure Information:

Title

Postoperative pain

Description

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)

Time Frame

Postoperative 48 hours

Title

Respiratory functions

Description

Time Frame

Postoperative 48 hours

Secondary Outcome Measure Information:

Title

Analgesic requirement. When the VRS was more than 4 points

Description

diclofenac (75 mg), tramadol (50mg)

Time Frame

Postoperative 48 hours

Title

Intensive care and hospital stay

Description

time for Intensive care and hospital (hours and days, respectively)

Time Frame

postoperative 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has ASA II-IV score Having open heart surgery Exclusion Criteria: Having a psychiatric illness Using analgesic medication due to chronic pain Uncooperative

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Engin Ertürk, Prof. Dr

Organizational Affiliation

Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Engin Ertürk

City

Ortahisar

State/Province

Trabzon

ZIP/Postal Code

61080

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all collected IPD

IPD Sharing Time Frame

starting12 months after publication

IPD Sharing Access Criteria

analyst and investigators

Learn more about this trial

Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries

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