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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02767-32 | Other Identifier | ANSM IDRCB number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Experimental group with intraoperative ANI monitoring of nociception | Experimental |
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| Arm B : Control group without ANI intraoperative monitoring of nociception | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A : intraoperative ANI monitoring of nociception | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France |
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| Arm B : no specific monitoring of nociception | Other | 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. |
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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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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