protocolSection identificationModule nctId: NCT06315959, orgStudyIdInfo id: ESPCHRONIC2023, briefTitle: Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Pain, conditions: Cardiac Surgery, conditions: Post Operative Pain, designModule 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, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral ultrasound guided erector spinae plane block, interventions name: morphine PCA, interventions name: Control group, interventions name: morphine PCA, outcomesModule primaryOutcomes measure: Chronic pain status, secondaryOutcomes measure: Postoperative opioid consumption in the first 24 Hours, secondaryOutcomes measure: Postoperative pain scores, secondaryOutcomes measure: The incidences of post-operative nausea and vomiting (PONV), secondaryOutcomes measure: The number of patient requiring rescue analgesic, secondaryOutcomes measure: Time to extubation, secondaryOutcomes measure: The number of patients with complications, secondaryOutcomes measure: Chronic pain status at 6 months., secondaryOutcomes measure: Length of stay in the ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayis University, status: RECRUITING, city: Samsun, state: Atakum, zip: 55139, country: Turkey, contacts name: BURHAN DOST, role: CONTACT, phone: 05327042493, email: burhandost@hotmail.com, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False