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

NCT ID: NCT06098859

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Respiratory Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thoracic epidural analgesia

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

Group Type ACTIVE_COMPARATOR

Thoracic epidural analgesia

Intervention Type PROCEDURE

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Erector spinae plane block

Erector spinae plane blockwas applied preoperatively

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

Erector spinae plane block was applied preoperatively using local anesthetic

Intravenous opioid analgesia

Intravenous opioid analgesia was administered during the surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thoracic epidural analgesia

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Intervention Type PROCEDURE

Erector spinae plane block

Erector spinae plane block was applied preoperatively using local anesthetic

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Engin Ertürk

Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Engin Ertürk, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Engin Ertürk

Ortahisar, Trabzon, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/184

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ESPB vs TPVB for Cardiac Surgery
NCT05476393 WITHDRAWN NA