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Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery (MONIALC)

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ClinicalTrials.gov Identifier: NCT04906187
Recruitment Status : Not yet recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasm Other: Arm A : intraoperative ANI monitoring of nociception Other: Arm B : no specific monitoring of nociception Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
Estimated Study Start Date : May 25, 2021
Estimated Primary Completion Date : February 25, 2023
Estimated Study Completion Date : August 25, 2023


Arm Intervention/treatment
Experimental: Arm A : Experimental group with intraoperative ANI monitoring of nociception Other: Arm A : intraoperative ANI monitoring of nociception
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.

Arm B : Control group without ANI intraoperative monitoring of nociception Other: Arm B : no specific monitoring of nociception
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 Measures :
  1. Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery. [ Time Frame: 3 months after 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 :
  1. Arm A : total dose of opioids received intraoperatively [ Time Frame: Surgery ]
  2. Arm B : total dose of opioids received intraoperatively [ Time Frame: Surgery ]
  3. Arm A : Patients' pain score on the VAS immediately postoperatively [ Time Frame: within one hour of extubation ]
    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.

  4. Arm B : Patients' pain score on the VAS immediately postoperatively [ Time Frame: within one hour of extubation ]
    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.

  5. Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery [ Time Frame: 3 months after surgery ]
  6. Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery [ Time Frame: 3 months after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Woman aged 18 years and over.
  2. Histologically proven ovarian carcinoma.
  3. Indication for laparotomy surgery with xyphopubic incision.
  4. Acceptance of epidural anesthesia.
  5. Pain score ≤ 3 (VAS or Numeric Verbal Scale).
  6. Free and informed consent.
  7. Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.

Exclusion Criteria:

  1. Heart rhythm disturbances.
  2. History of Cerebral Vascular Accident (CVA).
  3. History of epilepsy.
  4. Wearing a pacemaker.
  5. Receiving morphine treatment preoperatively.
  6. Medical contraindication to an epidural.
  7. Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
  8. Patient placed under guardianship or curatorship.
  9. Patient already included in the present study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906187


Contacts
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Contact: Arnaud DUBUISSON, Nurse (0)5.56.33.37.30 ext +33 a.dubuisson@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD, PhD s.mathoulin@bordeaux.unicancer.fr

Locations
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France
Institut Bergonié
Bordeaux, France, 33076
Contact: Arnaud DUBUISSON, Nurse       a.dubuisson@bordeaux.unicancer.fr   
Sponsors and Collaborators
Institut Bergonié
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT04906187    
Other Study ID Numbers: IB 2020-04
2020-A02767-32 ( Other Identifier: ANSM IDRCB number )
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Bergonié:
ovarian neoplasm
analgesia monitoring
pain measurement
Analgesia Nociception Index
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Chronic Pain
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Pain
Neurologic Manifestations