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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590013
• Other study ID #: Pectointercostal and ESP block
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2022
• Source: Cukurova University
• Contact: Ebru Biricik
• Phone: +905052420223
• Email: ebrubiricik01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Morphine consumption	Postoperative morphine consumption during the postoperative 24th hours	24 hours in Postanesthesia care unit (PACU)
Secondary	Ekstübation time	Time between end of the surgery and extubation of the patient	First 6 hours at Postanesthesia care unit (PACU)