Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
NCT ID: NCT07110857
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
346 participants
INTERVENTIONAL
2025-09-30
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Naropeine Arm
Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine)
Cervical plexus block with 0.2 % Naropeine
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
Placebo Arm
Superficial cervical plexus block with 0.9 % saline placebo
Cervical plexus block with saline placebo
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
Interventions
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Cervical plexus block with 0.2 % Naropeine
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
Cervical plexus block with saline placebo
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
Eligibility Criteria
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Inclusion Criteria
* Adult patient having received oral information from a doctor and signed written consent
* Affiliation to a social security scheme, Universal Medical Coverage (CMU)
Exclusion Criteria
* Altered mental faculties or patient unable to give consent
* Allergy to local anesthetics
* Severe respiratory pathology (altered respiratory function tests with 50% \< FEV1 \< 80%, FEV1/FVC \< 70%, COPD stage 2 or more)
* Preoperative SpO2 less than 92% in ambient air
* Left heart failure NYHA 3 or more, impaired LVEF \< 30% or less
* Lower respiratory infection in the month preceding surgery
* History of ENT cancer surgery with cervical lymph node dissection
* Pregnant or breastfeeding woman
* Patient under AME
* Patient under guardianship or reinforced curatorship
* Participation in other interventional research
18 Years
90 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Laetitia Desplanque
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU de Lille- Hôpital Roger Salengro
Lille, , France
Assistance publique - Hôpitaux de Marseille
Marseille, , France
AP-HP - Hôpital Lariboisière
Paris, , France
Assistance publique - Hôpitaux de Paris
Paris, , France
CHU Charles Nicolle
Rouen, , France
hôpital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Elsa JOZEFOWICZ
Role: primary
Role: backup
Sonia BOUKTHIR, Dr
Role: primary
Role: backup
Jean SELIM
Role: primary
Role: backup
Morgan Le Guen, Pr
Role: primary
Role: backup
Deborah TEMPESTA, Dr
Role: primary
Role: backup
Other Identifiers
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PHRCI-2022-38
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-510942-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
APHP230866
Identifier Type: -
Identifier Source: org_study_id
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