Clinical trial NCT05702151: ESP Block in Robotic Cardiac Surgery
Official title: Erector Spinae Plane Block in Robotic Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Postoperative Pain, Acute
Analgesia
Keywords: Robotic Cardiac Surgery
ESP Block
Postoperative Pain
Heart Valve disease
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Open Clinical Trial
Primary purpose: TREATMENT

Brief summary: Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic.

At 3 months the patients will be contacted to assess for pain and ask them for they life quality.

Detailed description: Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire.

The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description.

Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed.

Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours.

The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane.

An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room.

Both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. After the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously.

The pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. After acute phase of postoperative pain and typically until chest drainages are retired, the ESP catheter and the IV morphine will be withdrawn. After discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. Quality of life, pain and if present, its characteristics will be assessed.

Eligibility criteria: Inclusion Criteria:

* Robotic Cardiac Surgery
* Accepts to participate

Exclusion Criteria:

* Use of other regional anesthesia technics
* Presence of chronic Pain
* Psychiatric pathology, drug abuse
* Allergy or intolerance to local anesthetics

Primary outcomes:
measure: Accumulated opioid dose 12h
timeFrame: 12 postoperative hours
measure: Accumulated opioid dose 24h
timeFrame: 24 ostoperative hours
measure: Accumulated opioid dose 48h
timeFrame: 48 postoperative hours
measure: Visual Analogic Scale 12h
timeFrame: 12 postoperative hours
measure: Visual Analogic Scale 24h
timeFrame: 24 postoperative hours
measure: Visual Analogic Scale 48h
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: EQ 5-Dimensions 5-Levels
timeFrame: Preoperative and 3 months after surgery
measure: Brief Pain Scale
timeFrame: 3 months after surgery
measure: Neuropathic pain assessment
timeFrame: 3 postoperative months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References:
citation: Rovira Canudas I. [Postoperatory analgesia for minimally invasive cardiac surgery: which is the ideal technique?]. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):467-9. doi: 10.1016/j.redar.2012.07.010. Epub 2012 Sep 12. No abstract available. Spanish.
citation: Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.
citation: D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.