Cardiac Surgery, Chronic Postsurgical Pain, Postoperative Pain
Conditions
Keywords
cardiac anesthesia, chronic post-surgical pain, nerve blocks, Erector Spinae Plane Block, Superficial Parasternal Intercostal Plane Block
Brief summary
This multicentre, randomized, assessor-blinded, non-inferiority trial will compare the analgesic efficacy of bilateral superficial parasternal intercostal plane (SPIP) block with bilateral erector spinae plane (ESP) block in adults undergoing first-time on-pump cardiac surgery through median sternotomy. Participants will be randomly assigned in a 1:1 ratio to receive either SPIP or ESP block before induction of general anesthesia, in addition to standardized perioperative multimodal analgesia. The primary outcome is cumulative intravenous morphine milligram equivalent (IV-MME) consumption from extubation to 24 hours after extubation. The study will evaluate whether SPIP block is non-inferior to ESP block using a prespecified non-inferiority margin of 3 mg IV-MME.
Detailed description
This multicenter, parallel-group, randomized controlled non-inferiority trial will compare bilateral SPIP block with bilateral ESP block for postoperative analgesia in adults undergoing first-time on-pump cardiac surgery through median sternotomy. Patients aged 18-80 years will be enrolled across tertiary cardiac surgery centres in Türkiye and randomly assigned in a 1:1 ratio, stratified by center, to receive either bilateral SPIP block or bilateral ESP block. Both interventions will be performed before induction of general anesthesia. Participants in the SPIP group will receive ultrasound-guided injection between 4th and 5th ribs, whereas participants in the ESP group will receive bilateral ultrasound-guided injection at the T5 transverse process. Perioperative anesthesia, postoperative multimodal analgesia, and patient-controlled morphine analgesia will be standardised across participating centers. Postoperative outcome assessors will remain blinded to treatment allocation. Block success will be assessed using cold sensation testing before induction. The primary outcome is cumulative opioid consumption from extubation to 24 hours after extubation, expressed as intravenous morphine milligram equivalents (IV-MME). The primary objective is to determine whether SPIP block is non-inferior to ESP block using a prespecified non-inferiority margin of 3 mg IV-MME. Secondary outcomes include time-weighted average pain intensity at rest and during coughing over the first 24 hours after extubation, Quality of Recovery-15 scores at 24 hours and hospital discharge, and the incidence of chronic postsurgical pain at 3 months. Exploratory outcomes include rescue analgesic requirements, postoperative nausea and vomiting and other opioid-related adverse effects, time to extubation, intensive care unit and hospital length of stay, block failure, and block-related complications. The primary non-inferiority analysis will be performed in both the intention-to-treat and per-protocol populations. The between-group location shift in 24-hour IV-MME consumption will be estimated using the Hodges-Lehmann method with a two-sided 95% confidence interval. Non-inferiority will be concluded if the upper bound of the confidence interval for the SPIP minus ESP difference is less than 3 mg IV-MME.
Interventions
PROCEDUREBilateral Superficial Parasternal Intercostal Plane Block
Participants in the SPIP group will receive a bilateral ultrasound-guided SPIP block before induction of general anesthesia and systemic heparinization. With the participant supine, a high-frequency linear transducer will be placed parasagittally adjacent to the sternum. The needle will be advanced in-plane between the pectoral is major and external intercostal muscles. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be injected between the 4th and 5th ribs on each side (total 40 mL). In all participants, the surgeon will infiltrate 10 mL of 0.25% bupivacaine around the chest tube. The total bupivacaine dose will not exceed 3 mg/kg ideal body weight, with volume reduced proportionally if required.
PROCEDUREBilateral Erector Spinae Plane Block
Participants in the ESP group will receive a bilateral ultrasound-guided erector spinae plane block before induction of general anesthesia and systemic heparinization. With the participant sitting or lateral, a high-frequency linear transducer will be placed parasagittally to identify the T5 transverse process and erector spinae muscle. The needle will be advanced in-plane deep to the erector spinae muscle. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be injected on each side (total 40 mL). In all participants, the surgeon will infiltrate 10 mL of 0.25% bupivacaine around the chest tube. The total bupivacaine dose will not exceed 3 mg/kg ideal body weight, with volume reduced proportionally if required.
DRUGmorphine PCA
After extubation and recovery of adequate consciousness, intravenous patient-controlled analgesia (PCA) with morphine will be initiated. The PCA device will be programmed to deliver 1 mg of intravenous morphine per demand, with a 6-minute lockout interval, no background infusion, and a maximum dose of 20 mg over 4 hours. If pain persists at an NRS score of 4 or greater despite appropriate PCA use, additional intravenous morphine 1-3 mg may be administered as rescue analgesia. All PCA-delivered and rescue opioid doses will be recorded and converted to intravenous morphine milligram equivalents (IV-MME).
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an assessor-blinded trial. Participants and the anesthesiologists performing the regional block cannot be blinded because the SPIP and ESP blocks require different anatomical injection sites and may require different patient positioning. Postoperative outcome assessors and ICU staff performing structured study assessments will remain blinded to treatment allocation. The statistician will receive coded treatment groups and remain blinded until completion of the primary analysis.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: bilateral SPIP block or bilateral ESP block. Randomization will be stratified by participating centre, and participants will remain in their assigned group throughout follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* written informed consent * age 18 to 80 years * American Society of Anesthesiologists (ASA) physical status II-IV * Scheduled for first-time on-pump cardiac surgery through a median sternotomy, including coronary artery bypass grafting, valve repair or replacement, or another open cardiac procedure requiring sternotomy * Ability to understand postoperative pain and recovery assessments and to use an intravenous patient-controlled analgesia device.
Exclusion criteria
* Emergency surgery. * Previous median sternotomy. * Minimally invasive cardiac surgery without median sternotomy. * Known allergy or hypersensitivity to bupivacaine, morphine, paracetamol, ondansetron or another protocol medication. * Chronic opioid use, defined as continuous opioid treatment for at least 30 days at a daily oral morphine equivalent dose of 15 mg or more. * Alcohol or substance use disorder that, in the investigator's judgment, may affect adherence or outcome assessment. * Clinically significant hepatic dysfunction, defined as alanine aminotransferase or aspartate aminotransferase greater than twice the upper limit of normal. * Clinically significant renal dysfunction, defined as serum creatinine greater than twice the upper limit of normal. * Coagulation disorder or antithrombotic treatment that precludes safe block performance according to current institutional guidance. * Infection at a planned needle insertion site. * Severe psychiatric illness, cognitive impairment or communication difficulty preventing valid postoperative assessment. * Pregnancy or breastfeeding. * Body mass index greater than 40 kg/m². * Prolonged postoperative mechanical ventilation, defined as failure to achieve extubation within 8 hours after surgery. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption in the first 24 hours after surgery | From extubation to 24 hours after extubation | Total opioid consumption from extubation to 24 hours after extubation, including morphine delivered by patient-controlled analgesia and any additional rescue opioids. All opioid doses will be converted to intravenous morphine milligram equivalents (IV-MME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average pain intensity at rest | From extubation to 24 hours after extubation | Time-weighted average Numerical Rating Scale (NRS) pain intensity at rest over the first 24 hours after extubation, calculated from NRS scores obtained at 0, 6, 12, and 24 hours using the trapezoidal method. NRS ranges from 0 to 10, with higher scores indicating greater pain intensity. |
| Time-weighted average pain intensity during coughing | From extubation to 24 hours after extubation | Time-weighted average NRS pain intensity during coughing over the first 24 hours after extubation, calculated from assessments at 0, 6, 12, and 24 hours using the trapezoidal method. NRS ranges from 0 to 10, with higher scores indicating greater pain intensity. |
| Quality of Recovery-15 score at 24 hours | 24 hours after extubation | Quality of recovery assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. |
| Quality of Recovery-15 score at hospital discharge | At hospital discharge, up to postoperative day 30 | Quality of recovery assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. |
| Incidence of chronic postsurgical pain | 3 months after surgery | Incidence of chronic postsurgical pain defined according to International Classification of Diseases 11th Revision (ICD-11) criteria as pain that develops or increases after surgery, persists for at least 3 months, is localized to the sternotomy area or a relevant referred region, and is not better explained by another cause. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBurhan DOST, Assoc.Prof
CONTACTBurhan DOST
STUDY_DIRECTORBurhan DOST, Assoc.Prof
Ondokuz Mayıs University
Outcome results
None listed