Clinical trial

Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Chronic Pain Following Open Heart Surgery: A Prospective Randomized Controlled Trial

Name

ESPCHRONIC2023

Description

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.

Trial arms

Trial start

2024-04-01

Estimated PCD

2025-01-15

Trial end

2025-03-15

Status

Recruiting

Treatment

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.

Arms:

Group ESP

Other names:

erector spinae plane block

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).

Arms:

Group ESP

Other names:

PCA

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.

Arms:

Group Control

Other names:

control

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).

Arms:

Group Control

Other names:

PCA

Size

Primary endpoint

Chronic pain status

Postoperative 3rd month

Eligibility criteria

Inclusion Criteria: * Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy. * American Society of Anesthesiologists (ASA)classification II-III patients. * Patients who can use PCA. * Patients who will sign the informed consent form. Exclusion Criteria: * History of opioid use for more than four weeks * Chronic pain syndromes * Patients with a history of local anesthetic or opioid allergy, hypersensitivity * Alcohol and drug addiction * Conditions where regional anesthesia is contraindicated * Failure in the dermatomal examination performed after the block * Emergency surgeries and redo surgeries. * Individuals with obstructive sleep apnea. * Left ventricular ejection fraction less than 30%. * Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales. * Pregnant and breastfeeding patients. * Hematological disorders. * Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease). * Patients who cannot be extubated within the first 6 hours postoperatively.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

1 product

3 indications

Organization

Ondokuz Mayıs University

Product

Indication

Indication

Indication