Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery

Summary

The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale.

Conditions

• Chronic Pain
• Cardiac Surgery
• Post Operative Pain

Interventions

PROCEDURE

Bilateral ultrasound guided erector spinae plane block

Bilateral ultrasound-guided ESP(total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS). The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.

DRUG

morphine PCA

IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).

OTHER

Control group

Patients in this group will not be performed plane blocks. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS) . The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.

DRUG

morphine PCA

V PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).

Sponsors & Collaborators

• Ondokuz Mayıs University

  lead OTHER

Principal Investigators

• Burhan Dost · : Ondokuz Mayis Universitesi, Samsun, Atakum 55139

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2024-11-01

Completion

2025-02-20

Countries

• Turkey (Türkiye)

Study Locations