POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN. (OpiSpANI)
Primary Purpose
Scoliosis Idiopathic
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
THE ANALGESIA NOCICEPTIVE INDEX (ANI)
Sponsored by
About this trial
This is an interventional prevention trial for Scoliosis Idiopathic
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology, Robert Debre University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Analgesia Nociceptive Index (ANI)
No Analgesia Nociceptive Index (ANI)
Arm Description
Using ANI for guiding intraoperative opioid administration.
Do not use ANI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04047225
First Posted
August 5, 2019
Last Updated
October 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04047225
Brief Title
POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.
Acronym
OpiSpANI
Official Title
POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
April 26, 2022 (Anticipated)
Study Completion Date
October 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
THE ANALGESIA NOCICEPTIVE INDEX (ANI)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Analgesia Nociceptive Index (ANI)
Arm Type
Experimental
Arm Description
Using ANI for guiding intraoperative opioid administration.
Arm Title
No Analgesia Nociceptive Index (ANI)
Arm Type
No Intervention
Arm Description
Do not use ANI
Intervention Type
Device
Intervention Name(s)
THE ANALGESIA NOCICEPTIVE INDEX (ANI)
Other Intervention Name(s)
THE ANALGESIA NOCICEPTIVE INDEX
Intervention Description
Utilisation of the ANI during the operation
Primary Outcome Measure Information:
Title
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.
Description
Cumulative dose of morphine in first 24hrs post-operator
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Souhayl Dahmani, MD-PhD
Phone
+33140034183
Email
souhayl.dahmani@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Souhayl Dahmani, MD-PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Robert Debre University Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souhayl DAHMANI, MD,PhD
Phone
0033140034183
Email
souhayl.dahmani@aphp.fr
First Name & Middle Initial & Last Name & Degree
Souhayl DAHMANI, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.
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