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Not yet recruiting NCT07110857

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

No phase Interventional ENT Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cervical plexus block with 0.2 % Naropeine, Cervical plexus block with saline placebo.
Who it may be relevant to
Registry conditions: ENT Cancers. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Procedure 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
  • 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

Primary outcome measures

  • Amount of morphine [Time frame: The first 24 hours postoperatively]
Secondary outcome measures (10)
  • Remifentanil consumption [Time frame: Intraoperative]
  • Consumption of morphine [Time frame: In the first 72 hours postoperatively]
  • Evaluation in cervical VAS and flap site VAS score [Time frame: On arrival, 1 hour later, 2 hours later, 4 hours later]
  • Evaluation in cervical VAS in dynamic conditions and flap site VAS score [Time frame: Day 1, day 15 (or hospital discharge), 1 month and 3 months]
  • DN4 score assessment [Time frame: Day 1, Day 15 (or hospital discharge), 1 month and 3 month]
  • Evaluation of adverse effects attributable to morphine consumption [Time frame: Day 1, Day 15 (or hospital discharge)]
  • Evaluation of the rate of patients with early rehabilitation [Time frame: Initiated on Day 1]
  • The length of time spent in hospital [Time frame: Duration of hospital stay assessed up to 15 days or hospital discharge]
  • Evaluation of the E Satis MSO FNAH score [Time frame: Day 15 (or hospital discharge)]
  • Evaluation of the Mc Gill Pain score (SF-MPQ-2) [Time frame: Day 1, day 15 (or hospital discharge), 1 month and 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 7 centers
  • CHU de Lille- Hôpital Roger Salengro — Lille
  • Assistance publique - Hôpitaux de Marseille — Marseille
  • AP-HP - Hôpital Lariboisière — Paris
  • Assistance publique - Hôpitaux de Paris — Paris
  • CHU Charles Nicolle — Rouen
  • hôpital Foch — Suresnes
  • Institut Gustave Roussy — Villejuif

Identifiers

NCT: NCT07110857 · APHP230866 · PHRCI-2022-38 · 2024-510942-15-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗