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

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT06098859
Collaborator
(none)
93
1
3
8.1
11.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thoracic epidural analgesia
  • Procedure: Erector spinae plane block
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups
Primary Purpose:
Prevention
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''
Actual Study Start Date :
Jan 10, 2023
Actual Primary Completion Date :
Aug 28, 2023
Actual Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Thoracic epidural analgesia

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

Procedure: Thoracic epidural analgesia
Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Active Comparator: Erector spinae plane block

Erector spinae plane blockwas applied preoperatively

Procedure: Erector spinae plane block
Erector spinae plane block was applied preoperatively using local anesthetic

No Intervention: Intravenous opioid analgesia

Intravenous opioid analgesia was administered during the surgery

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain [Postoperative 48 hours]

    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)

  2. Respiratory functions [Postoperative 48 hours]

    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

  1. Analgesic requirement. When the VRS was more than 4 points [Postoperative 48 hours]

    diclofenac (75 mg), tramadol (50mg)

  2. Intensive care and hospital stay [postoperative 30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Engin Ertürk Ortahisar Trabzon Turkey 61080

Sponsors and Collaborators

  • Karadeniz Technical University

Investigators

  • Principal Investigator: Engin Ertürk, Prof. Dr, Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Engin Ertürk, Prof. Dr, Karadeniz Technical University
ClinicalTrials.gov Identifier:
NCT06098859
Other Study ID Numbers:
  • 2023/184
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Engin Ertürk, Prof. Dr, Karadeniz Technical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023