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

N/ANot Yet RecruitingNCT07110857

Assistance Publique - Hôpitaux de Paris346 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

346

Conditions

ENT Cancers

Interventions

Cervical plexus block with 0.2 % NaropeinePROCEDURE

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 placeboPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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.

Time frame: The first 24 hours postoperatively

Secondary Outcomes

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.

Time frame: Intraoperative

Consumption of morphine

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.

Time frame: 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.

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

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.

Time frame: Day 1, day 15 (or hospital discharge), 1 month and 3 months

Central Contacts

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

Data from ClinicalTrials.gov

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