NCT06267443

Brief Summary

Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable postoperative-pain

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

December 25, 2023

Last Update Submit

February 12, 2024

Conditions

Keywords

CPBGSpostop analgesiaESPBparasternal blocklocal anesthetic

Outcome Measures

Primary Outcomes (2)

  • postoperative analgesia

    postoperatively in the intensive care unit during mechanical ventilation behavioral pain, score, after extubation visüel analog scala will be used to measure postoperative pain of the patients. during mechanical ventilation every 2 hours after extübation 2., 4., 6., 8., 12., 24. hours

    24 hours after after surgery

  • postoperative atelectasia

    postoperatively at the 12. th and 24.th hours with ultrasonography the patients lungs will be sreened for atelectasis

    24 hours after after surgery

Secondary Outcomes (1)

  • postoperative mechanical ventilation duration

    24 hours after after surgery

Study Arms (2)

Group 1

ACTIVE COMPARATOR

in this group erector spina plane block will be performed before surgery for post operative analgesia

Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia

Group 2

ACTIVE COMPARATOR

in this group after endotracheal intubation bilateral parasternal block will be performed and to the chest tube sides local anesthetic infiltration will be performed

Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia

Interventions

Group 1: erector spina plane block: With USG guidance at the thoracal level of 4-5, with 20ml 2.5% bupivacaine ESPB will be performed. after surgery in the ICU pain score and atelectasia will be evaluated. Group 2: With USG guidance parasternal block will be performed after intubation bilaterally with 10 ml 0.25% bupivacaine each side. at the end of the surgery infiltration of chest tube sides will be performed with 10 ml 2.5% bupivacain.

Group 1Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo open heart surgery
  • Patients who agreed to participate in the study-

You may not qualify if:

  • Patients who do not agree to participate in the study
  • Patients with chronic lung disease
  • Patients with D. Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR DR

Study Record Dates

First Submitted

December 25, 2023

First Posted

February 20, 2024

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02