Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery

NCT ID: NCT07110857

Last Updated: 2025-08-08

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ENT Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Naropeine Arm

Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine)

Group Type EXPERIMENTAL

Cervical plexus block with 0.2 % Naropeine

Intervention Type 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

Placebo Arm

Superficial cervical plexus block with 0.9 % saline placebo

Group Type PLACEBO_COMPARATOR

Cervical plexus block with saline placebo

Intervention Type 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

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patient undergoing ENT cancer surgery with cervicotomy
* 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

* Patient refusal
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Assistance publique - Hôpitaux de Marseille

Marseille, , France

Site Status

AP-HP - Hôpital Lariboisière

Paris, , France

Site Status

Assistance publique - Hôpitaux de Paris

Paris, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

hôpital Foch

Suresnes, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Central Contacts

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Alexia EP

Role: CONTACT

01 40 27 18 63

Liliane HAMMANI-BERKANI

Role: CONTACT

01 56 09 37 62

Facility Contacts

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Elsa JOZEFOWICZ

Role: primary

Role: backup

Elsa Giuly yague, PH

Role: primary

Sonia BOUKTHIR, Dr

Role: primary

Role: backup

Laetitia Desplanque

Role: primary

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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