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

Study Overview
=================
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.

Official Title
-----------------
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.

Conditions
-----------------
Ovarian Neoplasm

Intervention / Treatment
-----------------
* Other: Arm A : intraoperative ANI monitoring of nociception
* Other: Arm B : no specific monitoring of nociception


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A : Experimental group with intraoperative ANI monitoring of nociception<br> | Other: Arm A : intraoperative ANI monitoring of nociception<br>* 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.<br>|
| Other: Arm B : Control group without ANI intraoperative monitoring of nociception<br> | Other: Arm B : no specific monitoring of nociception<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm A : total dose of opioids received intraoperatively |  | Surgery | 
| Arm B : total dose of opioids received intraoperatively |  | Surgery | 
| 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. | within one hour of extubation | 
| 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. | within one hour of extubation | 
| Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery |  | 3 months after surgery | 
| Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery |  | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian neoplasm, analgesia monitoring, pain measurement, Analgesia Nociception Index