Effect of Pectointercostal+ESP Block on Postoperatif Analgesia in Open Heart Surgery

NCT05590013 | Unknown Phase 4

• 1 other identifier: Pectointercostal and ESP block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks and 1 ml epinephrin will add to the each local anesthetic solutions. 10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Postoperative analgesia

  Visual analog scale (VAS) scores at the postoperative 24th hours. VAS scores define pain scores between 0-10. 0 reflects nopain, 10 reflects the worst pain.

  24 hours in Postanesthesia care unit (PACU)

• Morphine consumption

  Postoperative morphine consumption during the postoperative 24th hours

  24 hours in Postanesthesia care unit (PACU)

Secondary Outcomes (1)

• Ekstübation time

  First 6 hours at Postanesthesia care unit (PACU)

Study Arms (2)

Pectointercostal and ESP

ACTIVE COMPARATOR

Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block . Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery.

Drug: Pectointercostal and ESP block

Control Group

PLACEBO COMPARATOR

Block will not perform to the control group.

Drug: Pectointercostal and ESP block

Interventions

Pectointercostal and ESP block DRUG

Pectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally

Also known as: Fascial plane blocks

Control Group; Pectointercostal and ESP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II-III patients
• The patients who will operate for open heart surgery

You may not qualify if:

• The patients with Coagulopaty
• Allergy with local anesthetics
• infection at the injection sites
• Obesity (BMI \>35kg/m2)
• Liver and/or kidney failure

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01380, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ebru Biricik

  Cukurova University

  STUDY CHAIR

Central Study Contacts

Ebru Biricik

CONTACT

+905052420223; ebrubiricik01@gmail.com

Ebru Biricik

CONTACT

+903223386084; ebrubiricik01@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: November 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: April 27, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)