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

Determining to the Effect of Pectointercostal and ESP Block on Postoperative Analgesia During Open Heart Surgery

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)

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Pectointercostal and ESP block

Detailed Description

American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. 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 and block will not perform to the control group. 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. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the VAS score is higher than 4, the rescue analgesic diclofenac Na 75 mg will administer intravenously.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ebru Biricik; Phone Number: +905052420223; Email: ebrubiricik01@gmail.com
• Study Contact Backup: Name: Ebru Biricik; Phone Number: +903223386084; Email: ebrubiricik01@gmail.com

Study Locations

• Turkey
  • Adana, Turkey, 01380
    • Recruiting
    • Çukurova University
    • Contact: Ebru Biricik, MD; Phone Number: 05052420223; Email: ebrubiricik01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectointercostal and ESP; 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; Pectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally; Other Names: Fascial plane blocks
Placebo Comparator: Control Group; Block will not perform to the control group.	Drug: Pectointercostal and ESP block; Pectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally; Other Names: Fascial plane blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ekstübation time	Time between end of the surgery and extubation of the patient	First 6 hours at Postanesthesia care unit (PACU)

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Study Chair: Ebru Biricik, Çukurova University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Pectointercostal and ESP block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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