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| ID | Type | Description | Link |
|---|---|---|---|
| PHRCI-2022-38 | Other Grant/Funding Number | Ministry of health, France | |
| 2024-510942-15-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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This national, prospective, multicenter, randomized study aims to reduce the amount of intravenous morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.
The incidence of throat and neck (ENT) cancers is 15000 new cases/year in France. Nowadays, there are no studies with a sufficient level of evidence to establish formal recommendations on analgesic treatments to be applied in the context of ENT cancer surgery.
As cancer surgery causes severe acute postoperative pain and chronic pain, loco-regional anesthesia (LRA) plays an increasingly role in the prevention of this type of pain.
However, nowadays there is no data in the literature highlighting the interest of LRA in the context of ENT cancer surgery, despite a significant theoretical benefit.
The superficial cervical block, already used in carotid or thyroid surgery, has already shown its value. It seems logical to propose this block in throat and neck cancer surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naropeine Arm | Experimental | Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine) |
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| Placebo Arm | Placebo Comparator | Superficial cervical plexus block with 0.9 % saline placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical plexus block with 0.2 % Naropeine | Procedure | Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.2 % ropivacaine (Naropeine) uni- or bilateral depending on the surgical incision |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of morphine | The analysis metric is the cumulative amount of IV morphine (amount of morphine titrated in SSPI + administered by PCA in mg and mg/kg/day) during the first 24 hours postoperatively. | The first 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Remifentanil consumption | Change in remifentanil consumption during surgery per unit time (in µg/kg/min). The analysis metric is the cumulative sum of intraoperative remifentanil during surgery. | Intraoperative |
| Consumption of morphine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia EP | Contact | 01 40 27 18 63 | alexia.ep@aphp.fr | |
| Liliane HAMMANI-BERKANI | Contact | 01 56 09 37 62 | liliane.berkani@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laetitia Desplanque | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille- Hôpital Roger Salengro | Lille | 59000 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| Cervical plexus block with saline placebo | Procedure | Under ultrasound guidance, a superficial cervical plexus block is performed immediately after induction and before skin incision by injecting 15-25 mL of 0.9 % saline uni- or bilateral depending on the surgical incision |
|
Change in consumption of morphine equivalent intravenous or oral in the first 72 hours postoperatively (mg and mg/kg). The analysis metric is the cumulative amount of morphine administered during the first 72 hours postoperatively.
| In the first 72 hours postoperatively |
| Evaluation in cervical VAS and flap site VAS score | Change in cervical VAS (Visual Analog Scale) and flap site VAS score in PACU (post anesthesia care units). The VAS measures pain intensity on a scale from 0 to 10, with two end points representing 0 'no pain' and 10 'pain as bad as it could possibly be'. The analysis metric is the change from baseline. | On arrival, 1 hour later, 2 hours later, 4 hours later |
| Evaluation in cervical VAS in dynamic conditions and flap site VAS score | Change in cervical VAS (Visual Analog Scale) in dynamic conditions and flap site VAS score. The VAS measures pain intensity on a scale from 0 to 10, with two end points representing 0 'no pain' and 10 'pain as bad as it could possibly be'. The analysis metric is the change from baseline. | Day 1, day 15 (or hospital discharge), 1 month and 3 months |
| DN4 score assessment | DN4 (Douleur Neuropathique 4) score change. When the practitioner suspects neuropathic pain, the DN4 questionnaire is a useful diagnostic tool. If the patient's score is equal to or greater than 4/10, the test is positive indicating the presence of neuropathic pain. The analysis metric is the final value. | Day 1, Day 15 (or hospital discharge), 1 month and 3 month |
| Evaluation of adverse effects attributable to morphine consumption | Report / Change of adverse effects attributable to morphine consumption (desaturation, nausea-vomiting, etc.). The analysis metric is the difference between the post-processing value and the initial value. | Day 1, Day 15 (or hospital discharge) |
| Evaluation of the rate of patients with early rehabilitation | Change in the rate of patients with early rehabilitation: standing, wheelchair, physiotherapy | Initiated on Day 1 |
| The length of time spent in hospital | Reduction in the length of hospitalization between the control arm and the experimental arm. The analysis metric is the final value. | Duration of hospital stay assessed up to 15 days or hospital discharge |
| Evaluation of the E Satis MSO FNAH score | Improvement of the E-Satis MSO (medical-surgery-obstetrics) FNAH (French National Authority for Health) score. E-Satis is expressed out of 100. Score close to 100: positive experience | Day 15 (or hospital discharge) |
| Evaluation of the Mc Gill Pain score (SF-MPQ-2) | Improvement in Mc Gill Pain score (SF-MPQ-2). The McGill Pain Index is a self-assessment scale that describes the quality and intensity of pain from 0 to 50. A score close to 50 indicates extremely severe pain. | Day 1, day 15 (or hospital discharge), 1 month and 3 months |
| Assistance publique - Hôpitaux de Marseille | Marseille | 13005 | France |
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| AP-HP - Hôpital Lariboisière | Paris | 75010 | France |
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| Assistance publique - Hôpitaux de Paris | Paris | 75015 | France |
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| CHU Charles Nicolle | Rouen | 76000 | France |
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| hôpital Foch | Suresnes | 92150 | France |
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| Institut Gustave Roussy | Villejuif | 94805 | France |
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| ID | Term |
|---|---|
| D066008 | Cervical Plexus Block |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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