BCS-ORL - Evaluation of the superficial cervical plexus block in oncological throat and neck surgery

2024-510942-15-00 Protocol APHP230866 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 7 Apr 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 7 sites · Protocol APHP230866

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 346
Countries 1
Sites 7

Cancer surgery

The objective of this study is the reduction in the quantity of IV morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.

Key facts

Sponsor
Assistance Publique Hopitaux De Paris
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Otorhinolaryngologic Diseases [C09]
Trial duration
7 Apr 2026 → ongoing
Decision date (initial)
2025-05-28
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective of this study is the reduction in the quantity of IV morphine (titration + PCA morphine) during the first 24 postoperative hours via a locoregional anesthesia technique in patients undergoing throat and neck cancer surgery.

Secondary objectives 12

  1. Reduction in intraoperative remifentanil consumption per unit of time (in µg/kg/min)
  2. Reduction in consumption of morphine equivalent IV or PO in the first 72 hours postoperatively
  3. Reduction in VAS-cervical scores (on arrival, at H+1, H+2, H+4)
  4. Reduction in cervical VAS scores at rest on D1, D15, hospital discharge, 1 and 3 months
  5. Reduction in VAS scores on mobilization on D1, D15 and discharge from hospital
  6. Reduction in DN4 scores on D1, D15, hospital discharge, 1 and 3 months
  7. Evaluation of adverse effects attributable to LRA
  8. Evaluation of adverse effects attributable to morphine consumption (desaturation, nausea-vomiting, etc.) on D1, D15 and discharge from hospital
  9. Evaluation of the rate of patients with early rehabilitation: verticalization, chair, physiotherapy, initiated on D1
  10. Record of length of hospitalization
  11. Statement of Esatis MCO HAS score (item: “care”) upon discharge from hospital
  12. Record of the Mc Gill Pain score (SF-MPQ-2) on D1, on discharge from hospital, 1 and 3 months.

Conditions and MedDRA coding

Cancer surgery

VersionLevelCodeTermSystem organ class
20.0 PT 10074431 Cancer surgery 100000004865
20.0 SOC 10042613 Surgical and medical procedures 25

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Adult patient undergoing ENT cancer surgery with cervicotomy
  2. Patient having received oral information from a doctor and signed written consent
  3. Affiliation to a social security scheme, Universal Medical Coverage (CMU)

Exclusion criteria 10

  1. Patient refusal
  2. Altered mental faculties or patient unable to give consent
  3. Allergy to local anesthetics
  4. Severe respiratory pathology (altered respiratory function tests with 50% < FEV1 < 80%, FEV1/FVC < 70%, COPD stage 2 or more)
  5. Preoperative SpO2 less than 92% in ambient air
  6. Left heart failure NYHA 3 or more, impaired LVEF < 30% or less
  7. Lower respiratory infection in the month preceding surgery
  8. History of ENT cancer surgery with cervical lymph node dissection
  9. Pregnant or breastfeeding woman
  10. Patient under AME

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Quantity of morphine consumed postoperatively (quantity of morphine titrated in postoperative room + administered by the PCA in mg and mg/kg/d).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Ropivacaine

SUB10382MIG · Substance

Active substance
Ropivacaine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
50 ml millilitre(s)
Max total dose
50 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

251 Total trials 131 Recruiting 54 Ended
Academic / Non-commercial
Sponsor organisation
Assistance Publique Hopitaux De Paris
Address
Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City
Paris Cedex 10
Postcode
75475
Country
France

Scientific contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Laetitia DESPLANQUE

Public contact point

Organisation
Assistance Publique Hopitaux De Paris
Contact name
Laetitia DESPLANQUE

Locations

1 EU/EEA country · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 346 7
Rest of world — 0 —

Investigational sites

France

7 sites · Ongoing, recruiting
Centre Hospitalier Universitaire De Lille
Anesthésie Réanimation Spécialités chirurgicales, Rue Emile Laine, 59037, Lille Cedex
Hospital Foch
Anethésie et douleurs, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Regional De Marseille
Anesthésie et réanimation, 147 Boulevard Baille, 13005, Marseille
Centre Hospitalier Universitaire Rouen
Anesthésie et réanimation, 1 Rue De Germont, Bp 96031, Rouen Cedex
Institut Gustave Roussy
Anesthésie, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
Anesthésie-réanimation chirurgicale, 20 Rue Leblanc, 75015, Paris
Assistance Publique Hopitaux De Paris
Anesthésie et réanimation, 2 Rue Ambroise Pare, 75475, Paris Cedex 10

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2026-04-07 2026-04-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-510942-15-00 1-1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS-ICF 1-1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Ropivacaine 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG_2024-510942-15-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2024-510942-15-00 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-02-10 France Acceptable
2025-05-23
 2025-05-28

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