ESP Catheter Vs Single Shot ESP for Open Heart Surgery in Infants
Condition: Opioid Use; Pain, Postoperative; Quality of Life
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Post operative pain after open heart surgery is still a main concern; current multimodal
      analgesia modalities have shown good efficacy for postoperative pain at rest, without
      reaching full pain relief.

      The primary goal of this study is to evaluate the effectiveness of peri-operative analgesia,
      measured by consumption of opioids during the first 48h hours after the surgery, using
      bilateral erector spinae catheters for 48h, compared to single shot erector spinae block in
      pediatric patients undergoing open heart surgeries .
    

Detailed description: 
      Fast track to extubation after pediatric cardiothoracic surgery is becoming more common after
      a number of reports showing it is safe and effective . However, it has introduced new
      challenges to pain control. Intubated patients require larger doses of opioids and
      benzodiazepines for comfort . In patients who are awake and spontaneously breathing, pain and
      agitation cannot be treated with lower doses.

      Some centers still administer continuous infusions of opioid and benzodiazepines to extubated
      patients. These infusions may not be necessary and may even be harmful.

      In a pilot study of adult patients undergoing open heart surgery at VinMec hospitals,
      peri-operative regional analgesia by continuous bilateral erector spinae plane (ESP) block,
      Investigators showed that the pain relief was efficient and the requirement for opioids in
      the first 48 hours post-surgery was zero .

      It confirmed that the impact of regional anesthesia techniques on main procedure-specific
      postoperative outcomes is very important in decreasing opioid use in the context of
      fast-track recovery programs that are recommended after cardiac surgery.

      Since April 2017 Investigators are performing bilateral ESP single shot block in cardiac
      surgery on infants and children. In the post-operative period the patients still need 30
      hours after end of surgery small doses opioids to release their pain according to the
      evaluation by Comfort-B or/and FLACC Scales after the single shot blocks recovered. Since
      December 2017 Investigators are performing these surgeries with bilateral ESP catheters with
      an Intermittent infusion of very low doses of local anesthetic according to the guidelines ]
      in regional anesthesia analgesia in pediatric to improve the post-operative analgesia and
      avoid any opioids.

      The ESP block is an inter-fascial block described as a quite simple technique, far from risky
      anatomical structures. Since the first publication in November 2016 only one study on
      children has been published , in thoracic surgery.

      This technique has been presented at the 2018 World Congress on Regional Anesthesia and Pain
      Medicine as a opioid free pain free for open heart surgery in adult.

      Researchers from Stanford University reported also one case in open heart surgery announcing
      a new era in cardiac anesthesia in adult. A study in press shows the interest of a similar
      thoracic block named Serratus plane block in thoracic aortic surgery in newborn and infants .

      The study will be a double-blind randomized controlled trial. After informed consent from
      guardians or parents, infants and children will be randomized via a random number generator
      into one of two treatment groups.

        -  Group 1 (control) will receive a single shot dose of local anesthestic ropivacaine
           through ESP catheters and 6 hours later continuous infusion of Iso saline with a rescue
           analgesia in case of pain.

        -  Group 2 (treatment) will received a single shot dose of local anesthestic ropivacaine
           through ESP catheters and 6 hours later a continuous infusion of ropivacaine with a
           rescue analgesia in case of pain.

      Catheter Performance The anesthesia team will check that the catheter is inserted in the
      inter-fascial space rather than intra-vascular. This procedure will be bilateral. The
      catheter will have a yellow label on the Huer®-Lock connector to identify clearly that it is
      regional analgesia catheter to prevent any errors of miss injection. (Yellow is the
      international identification of regional anesthesia/analgesia lines).

      After this control an induction dose is injected according to the pediatric regional
      anesthesia analgesia guidelines.

        -  If < 1 year old Ropivacaine 0.1% 0.25 mg/kg/side

        -  If >= 1 year old Ropivacaine 0.2% 0.50 mg/kg/side

      After 7h the ESP catheter has been placed, one of the clinical research nurses will proceed
      to the randomization of the patient according to the randomization table, and prepare the
      solution (100 mL) in the pump as per protocol. They will put the ID number of patient on the
      pump. The nurse will receive instruction to keep strictly confidential the content of the
      pumps. They will deliver the prepared pumps to the anesthesiologist and anesthesia nurse in
      charge of the patient. They will connect the pumps to the patient and start the infusion 8
      hours after regional anesthesia induction as per protocol.

        -  Group 1 (control group) will receive an automatic Iso Saline infusion through the 2 ESP
           catheters. The infusion regimen will be Intermittent automatic bolus (IAB) every 8 hours
           of 0.5mL/kg/side. The bolus on the second catheter will be delayed by 2 hours.

        -  Group 2 (Continuous regional analgesia group) will receive an automatic infusion of
           Ropivacaine (see above for concentration according to age) through the 2 ESP catheters.
           The infusion regimen will be IAB every 8 hours 0.5mL/kg-side. The bolus on the second
           catheter will be delayed by 2 hours to reduce the maximal plasmatic concentration as
           much as possible.

      Both groups will receive paracetamol 15 mg/kg every 6 hr.

      For all groups pain will be defined according to COMFORT Scale > 17 or FLACC scale > 3.

      Management of the pain

        1. If pain appears before next IAB the delay between 2 IAB will be reduced to 6 hr without
           adding any medication This is a common practice in peripheral nerve management.

        2. If the block extension is insufficient (T1 to T9) , IAB will be increased by 0,1
           mL/catheter of the solution inside the pump on the side concerned: by increasing the
           volume by 10% Investigators will increase the extension of the analgesia block. This
           increase in volume will be limited to one increase.

      1+ 2/ If pain still persists after 1 hour the patient will be shifted to rescue analgesia
      described below (3) .

      3/ If non of those (1 or 2) patient will receive rescue analgesia start Ibuprofen 10mg/kg/12
      h All participants in the studies were trained to the protocol in January 2018; the research
      nurses were trained to randomization and data collection.

      Pain will be reassessed 1 hour after 3a if the FLACC < 3: continue ESP catheters and
      paracetamol+ ibuprofen /12h if the FLACC >3 = poor analgesia Investigators will add analgesia
      by opioids as before this technique and commonly used in open heart surgeries in infants o
      Morphine 30 mcg/kg/h.

      A Bi Daily inspection of the catheters insertion points will be done. If redness around
      puncture point the catheters will be removed and shift to classical IV analgesia to prevent
      any infection. It will be declared as a minor incident in the study.

      ESP catheters will be removed 2 hours after drain removal maximum 46h after insertion.

      2 h. after Drain removal and ESP catheter removed the analgesia in both group will be with
      the following antalgics: Efferalgan : 15-20 mg/kg /6h and Ibuprofen sirop : 10 mg/kg/12h

      Pain scales Investigators will use to evaluate the pain:

      When patient will be intubated Investigators will use scale Comfort-B . at rest and after
      pressure on sternum or drain mobilization (Mob).

      After extubation and still drains will remain Investigators will use FLACC scale at rest and
      at Mob (sitting in bed rotation of the thorax) analysis of the Localization of the pain

        -  Sternum

        -  Back pain

        -  Drains o After drains removal Investigators will use FLACC Scale rest and Mob ( sitting
           in bed rotation of the thorax) and pain localization

      One month after the surgery a pain assessment will be done during the 1st one month follow up
      with a FLACC scale (rest and Mobilisation) and also analyze if the patient is playing
      normally according to his parents or guardians

      Statistical analysis

      Based on our prior institutional unpublished retrospective data of morphine consumption in
      the first 48H after the surgery (End of surgery to 48h after end of surgery) in patients who
      received Single shot ESP bl0cks who underwent open heart surgeries (control group) (mean
      0.998 mg/kg) with standard deviation 0.323) Treated group = 0 mg/kg Investigators determine
      that a total of 14 patients per arm will be needed to achieve a difference of 0.4 between the
      2 groups with 90% power at alpha =0.05. Investigators will assume up to 10% lost to follow up
      and 10% of patients would be non-compliant so Investigators will enroll 20 patients in each
      group.
    

Intervention name(s): Continuous infusion of ropivacain in ESP catheter; Continuous infusion of Iso Saline in ESP catheter
Intervention type(s): Drug; Drug
Intervention description(s): administration of ropivacaine in ESP catheter to provide regional analgesia after surgery; administration of Iso Saline in ESP catheter to be the control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment