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

Phase 4

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Pectointercostal and ESP block

• Registration Number: NCT05590013
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Study Start: 2022-11-15
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Pectointercostal and ESP block	Block will not perform to the control group.
Pectointercostal and ESP	Pectointercostal and ESP block	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.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia	24 hours in Postanesthesia care unit (PACU)	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	24 hours in Postanesthesia care unit (PACU)	Postoperative morphine consumption during the postoperative 24th hours

Secondary Outcome Measures

Name	Time	Method
Ekstübation time	First 6 hours at Postanesthesia care unit (PACU)	Time between end of the surgery and extubation of the patient

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey