Comparison of the effect of spinal erector plane block versus preoperatively extrapleural inserted catheter in postoperative pain control in mini-invasive cardiac surgery
| ISRCTN | ISRCTN80252380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80252380 |
| Sponsor | Charles University |
| Funder | Investigator initiated and funded |
- Submission date
- 28/02/2026
- Registration date
- 14/04/2026
- Last edited
- 14/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary of protocol not provided at time of registration
Contact information
Dr Jan Kunstyr
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
General University Hospital in Prague
U Nemocnice 499/2
Prague 2
128 08
Czech Republic
 ORCID ID |
0000-0002-3659-7764 |
|---|---|
| Phone | +420 724828725 |
| jan.kunstyr@vfn.cz |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Participant information sheet | 49118_PIS.pdf |
| Scientific title | Efficacy of erector spinae plane block versus extrapleural catheter analgesia for postoperative pain control in minimally invasive cardiac surgery |
| Study objectives | The main study objective is to compare postoperative pain between two groups of patients treated with two different types of analgesia |
| Ethics approval(s) |
Approved 19/02/2026, Etická komise VFN Praha (Na Bojišti 1, Praha, 128 08, Czech Republic; +420 224964131; eticka.komise@vfn.cz), ref: 199/25 S-IV |
| Health condition(s) or problem(s) studied | Acute postoperative pain following minimally invasive cardiac surgery |
| Intervention | Randomisation is performed using a computer-generated random allocation sequence with permuted blocks of variable size (4 and 8). Allocation concealment is ensured using sequentially numbered, opaque, sealed envelopes prepared according to the randomisation list. Envelopes are opened only after eligibility confirmation and written informed consent. Participants and outcome assessors are blinded to treatment allocation. Enrolled patients will be randomly assigned to either the erector spinae plane block (ESPB) group or the extrapleural catheter (EPC) group. In the ESPB group, an ultrasound-guided catheter will be inserted preoperatively in the sitting position between the transverse process of the fifth thoracic vertebra and the erector spinae muscle. In the EPC group, an extrapleural catheter will be inserted by the surgeon under direct vision immediately before wound closure. All patients will undergo standardized total intravenous anesthesia with propofol and remifentanil and left-sided double-lumen endotracheal intubation. Mechanical ventilation will be adjusted to maintain adequate oxygenation and ventilation. Surgical access will be through a left fifth intercostal incision with placement of a chest drain. In both groups, 30 mL of 0.25% bupivacaine will be administered via the catheter before skin closure, followed by continuous infusion of 0.125% bupivacaine at 3–8 mL/h. Postoperative multimodal analgesia will include intravenous paracetamol and metamizole. Rescue analgesia will be provided with hydromorphone as needed. Pain scores, opioid-related adverse events, duration of intubation, intensive care unit stay, and total hospital length of stay will be recorded. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/01/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Patients aged between 18 and 80 years 2. Scheduled for mini-invasive direct coronary artery bypass (MIDCAB) via thoracotomy |
| Key exclusion criteria | 1. Body mass index less than 18 or greater than 30 kg/m2 2. Emergency or redo surgery 3. Contraindications to the use of regional blocks 4. Diagnosed psychiatric disorder 5. History of opioid addiction 6. With chronic or neuropathic pain 7. Patient refusal |
| Date of first enrolment | 23/02/2026 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 09/03/2026 | No | No | ||
| Participant information sheet | 09/03/2026 | No | Yes | ||
| Protocol file | version 2 | 09/03/2026 | No | No |
Additional files
- 49118 _PROTOCOL_v2.pdf
- Protocol file
- 49118_PIS.pdf
- Participant information sheet
- 49118_InformedConsent.pdf
- Other files
Editorial Notes
09/03/2026: Study's existence confirmed by the Ethics Committee of the General University Hospital.
