Trials Sponsors Conditions Drugs Pricing

Conditions

Ovarian Neoplasm

Keywords

ovarian neoplasmanalgesia monitoringpain measurementAnalgesia Nociception Index

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

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
within one hour of extubation
Arm B : Patients' pain score on the VAS immediately postoperatively
within one hour of extubation
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
3 months after surgery
+1 more secondary outcomes

Study Arms (2)

Arm A : Experimental group with intraoperative ANI monitoring of nociception

EXPERIMENTAL

Other: Arm A : intraoperative ANI monitoring of nociception

Arm B : Control group without ANI intraoperative monitoring of nociception

OTHER

Other: Arm B : no specific monitoring of nociception

Interventions

Arm A : intraoperative ANI monitoring of nociceptionOther

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 A : Experimental group with intraoperative ANI monitoring of nociception

Arm B : no specific monitoring of nociceptionOther

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.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Woman aged 18 years and over.
Histologically proven or strongly suspected ovarian carcinoma.

Sponsors & Collaborators

Institut Bergonié
Otherlead

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Enrollment

126 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 28, 2021

Study Start

May 31, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A : Experimental group with intraoperative ANI monitoring of nociception

Arm B : Control group without ANI intraoperative monitoring of nociception

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A : Experimental group with intraoperative ANI monitoring of nociception

Arm B : Control group without ANI intraoperative monitoring of nociception

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations