Ovarian NeoplasmMONIALCNCT04906187
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
A study testing Arm A : intraoperative ANI monitoring of nociception and Arm B : no specific monitoring of nociception in people with Ovarian Neoplasm, run by Institut Bergonié at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm
- What is being tested?
- Arm A : intraoperative ANI monitoring of nociception and Arm B : no specific monitoring of nociception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2021to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
- Medical contraindication to an epidural.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
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.
Read the 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.
- Conditions
- Ovarian Neoplasm
- Being tested
- Arm A : intraoperative ANI monitoring of nociception, Arm B : no specific monitoring of nociception
- Keywords
- ovarian neoplasm, analgesia monitoring, pain measurement, Analgesia Nociception Index
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Experimental group with intraoperative ANI monitoring of nociception | Experimental | Not described Receives: Other: Arm A : intraoperative ANI monitoring of nociception |
| Arm B : Control group without ANI intraoperative monitoring of nociception | Other | Not described Receives: Other: Arm B : no specific monitoring of nociception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (6)
Arm A : total dose of opioids received intraoperatively
Measured: Surgery
Arm B : total dose of opioids received intraoperatively
Measured: 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.
Measured: 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.
Measured: within one hour of extubation
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Measured: 3 months after surgery
Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start31 May 2021
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906187
- Sponsor's protocol ID
- IB 2020-04
- Other IDs
- 2020-A02767-32
- Acronym
- MONIALC
- Status last verified
- Sep 2026
- First submitted
- 20 May 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
- ClinicalTrials.gov ID
- NCT04906187
- Acronym / sponsor ID
- MONIALC / IB 2020-04
- Conditions
- Ovarian Neoplasm
- Keywords
- ovarian neoplasm, analgesia monitoring, pain measurement, Analgesia Nociception Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A : intraoperative ANI monitoring of nociceptionFor 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. | Other | Arm A : Experimental group with intraoperative ANI monitoring of nociception |
| Arm B : no specific monitoring of nociceptionFor 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. | Other | Arm B : Control group without ANI intraoperative monitoring of nociception |
Primary outcome
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.
6 secondary outcomes
Arm A : total dose of opioids received intraoperatively
Time frame: Surgery
Arm B : total dose of opioids received intraoperatively
Time frame: Surgery
Arm A : Patients' pain score on the VAS immediately postoperatively
Time frame: within one hour of extubation
Arm B : Patients' pain score on the VAS immediately postoperatively
Time frame: within one hour of extubation
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Time frame: 3 months after surgery
Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A : intraoperative ANI monitoring of nociception and Arm B : no specific monitoring of nociception in people with Ovarian Neoplasm, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery. (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.