POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN. (OpiSpANI)

Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as heart rate and blood pressure variations. However, many studies in both adults and children have shown the poor accuracy of those parameters in predicting pain because of their sensibility to other intraoperative events such as depth of anaesthesia and volaemic variations. Consequently, intraoperative analgesia is still inadequately managed with periods of under dosage or over dosage of opioid agents. This has been hypothesized to cause postoperative hyperalgesia related to both intraoperative pain (in case of under dosage) or to opioid agents (in case of over dosage). The main resulting effect is an increase of postoperative opioid consumption and the inadequate postoperative rehabilitation because of adverse effects of opioids.

During the last decade, many pain-monitors have been investigated. Most of these devices are relying on the determination of the sympathetic-to the parasympathetic systems balance. Among those monitors, the Analgesia Nociceptive Index (ANI) quantifies the parasympathetic system. The ANI device can produce two parameters the instantaneous ANI (ANIi), derived from 60 seconds analysis and the mean ANI (ANIm) derived from 4 minutes analysis. Studies have shown the accuracy of ANIi to detect both experimental and clinical pain in various populations. Moreover, a recent randomized controlled trial during spine surgery in adults has found ANIi to decrease the intraoperative and postoperative opioid consumption when used intraoperatively for guiding the administration of opioid agents

Study Overview

• Status: Recruiting
• Conditions: Scoliosis Idiopathic
• Intervention / Treatment: Device: THE ANALGESIA NOCICEPTIVE INDEX (ANI)

Detailed Description

Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as heart rate and blood pressure variations. However, many studies in both adults and children have shown the poor accuracy of those parameters in predicting pain because of their sensibility to other intraoperative events such as depth of anaesthesia and volaemic variations. Consequently, intraoperative analgesia is still inadequately managed with periods of under dosage or over dosage of opioid agents. This has been hypothesized to cause postoperative hyperalgesia related to both intraoperative pain (in case of under dosage) or to opioid agents (in case of over dosage). The main resulting effect is an increase of postoperative opioid consumption and the inadequate postoperative rehabilitation because of adverse effects of opioids.

During the last decade, many pain-monitors have been investigated. Most of these devices are relying on the determination of the sympathetic-to the parasympathetic systems balance. Among those monitors, the Analgesia Nociceptive Index (ANI) quantifies the parasympathetic system. The ANI device can produce two parameters the instantaneous ANI (ANIi), derived from 60 seconds analysis and the mean ANI (ANIm) derived from 4 minutes analysis. Studies have shown the accuracy of ANIi to detect both experimental and clinical pain in various populations. Moreover, a recent randomized controlled trial during spine surgery in adults has found ANIi to decrease the intraoperative and postoperative opioid consumption when used intraoperatively for guiding the administration of opioid agents

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Souhayl Dahmani, MD-PhD; Phone Number: +33140034183; Email: souhayl.dahmani@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Department of Anesthesiology, Robert Debre University Hospital
    • Contact: Souhayl DAHMANI, MD,PhD; Phone Number: 0033140034183; Email: souhayl.dahmani@aphp.fr
    • Principal Investigator: Souhayl DAHMANI, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age < 18 years at time of surgery;
• Surgical correction of idiopathic scoliosis with or without thoracoplasty;
• Weight ≥ 30 kg : in order to allow using target plasma concentration administration of the opioid (remifentanil) and anaesthetic (propofol) agents; (pharmacokinetics models are not validated under this weight) during the intraoperative period;
• ASA (American Society of Anesthesiologist) status I to III
• Affiliation to the French national health insurance

Exclusion Criteria:

• Second time of a scoliosis correction in the preceding year (apart the use of halo-gravity traction or non-painful procedures such as digestive endoscopy);
• Chronic treatment (> 3 months) with: opioid agents, anti-epileptic agents or anti-depressant agents;
• Bad French language understanding;
• Expected difficulties in self-managing pain using the patient-controlled analgesia devices;
• ASA (American Society of Anesthesiologist) status IV or V;
• Any contraindication to one of the compound of the study: propofol, remifentanil, atracurium, paracetamol, Non-steroidal anti-inflammatory agents.
• Patients with a heart pace-maker device
• Patient under anti-arrythmic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Analgesia Nociceptive Index (ANI); Using ANI for guiding intraoperative opioid administration.	Device: THE ANALGESIA NOCICEPTIVE INDEX (ANI); Utilisation of the ANI during the operation; Other Names: THE ANALGESIA NOCICEPTIVE INDEX
No Intervention: No Analgesia Nociceptive Index (ANI); Do not use ANI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the cumulative dose (in mg) of morphine during the first postoperative 24 hours according to the use or not of the ANI monitor (ANIi parameter) for guiding intraoperative opioid administration.	Cumulative dose of morphine in first 24hrs post-operator	24 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Souhayl Dahmani, MD-PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Anticipated): April 26, 2022
• Study Completion (Anticipated): October 26, 2022

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: ID-RCB 2019-A01388-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No