ESP Block in Robotic Cardiac Surgery

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05702151

Collaborator

(none)

Enrollment

Location

Arms

17.3

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases Postoperative Pain, Acute Analgesia	Procedure: ESP Block Drug: Morphine injection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Randomized Open Clinical TrialProspective Randomized Open Clinical Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Erector Spinae Plane Block in Robotic Cardiac Surgery

Actual Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Morphine infusion 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.	Drug: Morphine injection Intravenous morphine infusion 50mcg/kg/h with Patient Controlled Analgesia extra bolus on demand (1mg bolus with 20 minutes lockout time), and paracetamol 1g every 8 hours. Other Names: Intravenous opioid infusion analgesia and paracetamol
Experimental: ESP Block analgesia 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.	Procedure: ESP Block 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. Ropivacaine 0.2% infusion at a 10ml/h rate is started during the surgery. Other Names: Erector spinae Plane Block Drug: Morphine injection Intravenous morphine infusion 50mcg/kg/h with Patient Controlled Analgesia extra bolus on demand (1mg bolus with 20 minutes lockout time), and paracetamol 1g every 8 hours. Other Names: Intravenous opioid infusion analgesia and paracetamol

Arm

Intervention/Treatment

Active Comparator: Morphine infusion

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.

Drug: Morphine injection

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

Other Names:

Intravenous opioid infusion analgesia and paracetamol

Experimental: ESP Block analgesia

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.

Procedure: ESP Block

Other Names:

Erector spinae Plane Block

Drug: Morphine injection

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

Other Names:

Intravenous opioid infusion analgesia and paracetamol

Outcome Measures

Primary Outcome Measures

Accumulated opioid dose 12h [12 postoperative hours]
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 24h [24 ostoperative hours]
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 48h [48 postoperative hours]
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Visual Analogic Scale 12h [12 postoperative hours]
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 24h [24 postoperative hours]
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 48h [48 postoperative hours]
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.

Secondary Outcome Measures

EQ 5-Dimensions 5-Levels [Preoperative and 3 months after surgery]
Quality of Life measure with EQ 5D 5L scale, created by the Euro QL group and used to measure life quality, its a scale describing 5 dimensions of life (Mobility, Self care, General activity, pain and discomfort, anxiety and depression) in 5 levels of comfort/discomfort (Score of 1 in each dimensions describes the most comfort). It can be expressed separately or by combining them into an index generated with a standard calculator provided by the EQL group.
Brief Pain Scale [3 months after surgery]
Pain presence and its characteristics 3 months after surgery described by the brief pain scale. This standard scale describes the pain intensity from 1 to 10 (being 10 the most intense pain) and and DN4 scale will be performed.
Neuropathic pain assessment [3 postoperative months]
When pain is present, assessment for neuropathic pain characteristics will be assessed using the Douleur neuropathique 4 (DN4) scale, spanish version. This scale assess 10 characteristics of pain, with a maximum score of 10, minimum of 0. Interpreted as positive (neuropathic pain likely) with a score of 7 or more.