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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pectointercostal and ESP block
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pectointercostal and ESP

Control Group

Arm Description

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.

Block will not perform to the control group.

Outcomes

Primary Outcome Measures

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.
Morphine consumption
Postoperative morphine consumption during the postoperative 24th hours

Secondary Outcome Measures

Ekstübation time
Time between end of the surgery and extubation of the patient

Full Information

First Posted
October 18, 2022
Last Updated
April 26, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05590013
Brief Title
Effect of Pectointercostal+ESP Block on Postoperatif Analgesia in Open Heart Surgery
Official Title
Determining to the Effect of Pectointercostal and ESP Block on Postoperative Analgesia During Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

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

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pectointercostal and ESP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Block will not perform to the control group.
Intervention Type
Drug
Intervention Name(s)
Pectointercostal and ESP block
Other Intervention Name(s)
Fascial plane blocks
Intervention Description
Pectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
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.
Time Frame
24 hours in Postanesthesia care unit (PACU)
Title
Morphine consumption
Description
Postoperative morphine consumption during the postoperative 24th hours
Time Frame
24 hours in Postanesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Ekstübation time
Description
Time between end of the surgery and extubation of the patient
Time Frame
First 6 hours at Postanesthesia care unit (PACU)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Biricik
Phone
+905052420223
Email
ebrubiricik01@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Biricik
Phone
+903223386084
Email
ebrubiricik01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik
Organizational Affiliation
Çukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik, MD
Phone
05052420223
Email
ebrubiricik01@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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