Back to resultsImpact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery (MONIALC)
Primary Purpose
Ovarian Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arm A : intraoperative ANI monitoring of nociception
Arm B : no specific monitoring of nociception
Sponsored by
About this trial
This is an interventional other trial for Ovarian Neoplasm focused on measuring ovarian neoplasm, analgesia monitoring, pain measurement, Analgesia Nociception Index
Eligibility Criteria
Inclusion Criteria:
- Woman aged 18 years and over.
- Histologically proven ovarian carcinoma.
- Indication for laparotomy surgery with xyphopubic incision.
- Acceptance of epidural anesthesia.
- Pain score ≤ 3 (VAS or Numeric Verbal Scale).
- Free and informed consent.
- Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.
Exclusion Criteria:
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
- Medical contraindication to an epidural.
- Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient already included in the present study.
Sites / Locations
- Institut BergoniéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm A : Experimental group with intraoperative ANI monitoring of nociception
Arm B : Control group without ANI intraoperative monitoring of nociception
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Secondary Outcome Measures
Arm A : total dose of opioids received intraoperatively
Arm B : total dose of opioids received intraoperatively
Arm A : Patients' pain score on the VAS immediately postoperatively
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Arm B : Patients' pain score on the VAS immediately postoperatively
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04906187
Brief Title
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
Acronym
MONIALC
Official Title
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
August 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-center, randomized, phase II, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ANI (Analgesia Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.
Detailed Description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
Before inclusion,all eligibility criteria will be verified, VAS pain score and VAS anxiety will be performed.
The surgical procedure for ovarian carcinoma will be performed by laparotomy and the intraoperative monitoring of nociception wil depend of the randomization arm : Intraoperative ANI monitoring of nociception (experimental arm) versus no specific monitoring of nociception (control arm). The total dose of opioids (in micrograms) received by the patients will be recorded at the end of the surgery.
VAS pain score will be performed immediately postoperatively and at three months after the intervention. A DN4 questionnaire (neuropathic pain) will be evaluated at three months after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasm
Keywords
ovarian neoplasm, analgesia monitoring, pain measurement, Analgesia Nociception Index
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A : Experimental group with intraoperative ANI monitoring of nociception
Arm Type
Experimental
Arm Title
Arm B : Control group without ANI intraoperative monitoring of nociception
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Arm A : intraoperative ANI monitoring of nociception
Intervention Description
For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics.
Intervention Type
Other
Intervention Name(s)
Arm B : no specific monitoring of nociception
Intervention Description
For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics.
Primary Outcome Measure Information:
Title
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
Description
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Arm A : total dose of opioids received intraoperatively
Time Frame
Surgery
Title
Arm B : total dose of opioids received intraoperatively
Time Frame
Surgery
Title
Arm A : Patients' pain score on the VAS immediately postoperatively
Description
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Time Frame
within one hour of extubation
Title
Arm B : Patients' pain score on the VAS immediately postoperatively
Description
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Time Frame
within one hour of extubation
Title
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Time Frame
3 months after surgery
Title
Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman aged 18 years and over.
Histologically proven or strongly suspected ovarian carcinoma.
Indication for laparotomy surgery with xyphopubic incision.
Acceptance of epidural anesthesia.
Pain score ≤ 3 (VAS or Numeric Verbal Scale).
Free and informed consent.
Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.
Exclusion Criteria:
Heart rhythm disturbances.
History of Cerebral Vascular Accident (CVA).
History of epilepsy.
Wearing a pacemaker.
Receiving morphine treatment preoperatively.
Medical contraindication to an epidural.
Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
Patient placed under guardianship or curatorship.
Patient already included in the present study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud DUBUISSON, Nurse
Phone
(0)5.56.33.37.30
Ext
+33
Email
a.dubuisson@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD, PhD
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud DUBUISSON, Nurse
Email
a.dubuisson@bordeaux.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
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