ESP Block in Robotic Cardiac Surgery

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Heart Valve Diseases; Postoperative Pain, Acute; Analgesia

Treatments: Drug: Morphine injection; Procedure: ESP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05702151

ESProbot001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Morphine infusion

Active Comparator group

Description:

IV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours.

Treatment:

Drug: Morphine injection

ESP Block analgesia

Experimental group

Description:

After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered.

Treatment:

Drug: Morphine injection

Procedure: ESP Block