Clinical Trial Radar

Name: Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
Creator: Assistance Publique - Hôpitaux de Paris
Published: 2025-08-08
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07110857 (BCS-ORL) for ENT Cancers is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery (BCS-ORL) 346 Randomized

Not yet recruiting

Clinical Trial NCT07110857 (BCS-ORL) is an interventional study for ENT Cancers and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 346 participants. Led by Assistance Publique - Hôpitaux de Paris, this study is expected to complete by 1 September 2027. The latest data from ClinicalTrials.gov was last updated on 8 August 2025.

Brief Summary

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...

Official Title

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

Conditions

ENT Cancers

Other Study IDs

BCS-ORL
APHP230866
PHRCI-2022-38 (Other Grant/Funding Number) (Ministry of health, France)
2024-510942-15-00 (EU Study (CTIS) Number)

NCT ID Number

NCT07110857

Start Date (Actual)

2025-09

Last Update Posted

2025-08-08

Completion Date (Estimated)

2027-09

Enrollment (Estimated)

346

Study Type

Interventional

PHASE

N/A

Status

Not yet recruiting

Keywords

the superficial cervical plexus block
surgery
locoregional anesthesia
locoregional analgesia
ENT surgery

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Triple

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalNaropeine 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 ComparatorPlacebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 1, day 15 (or hospital discharge), 1 month and 3 months
DN4 score assessment	DN4 (Douleur Neuropathique 4) score change. When the practitioner suspects neuropathic pain, the DN4 questionnaire is a useful diagnostic tool. If the patient's score is equal to or greater than 4/10, the test is positive indicating the presence of neuropathic pain. The analysis metric is the final value.	Day 1, Day 15 (or hospital discharge), 1 month and 3 month
Evaluation of adverse effects attributable to morphine consumption	Report / Change of adverse effects attributable to morphine consumption (desaturation, nausea-vomiting, etc.). The analysis metric is the difference between the post-processing value and the initial value.	Day 1, Day 15 (or hospital discharge)
Evaluation of the rate of patients with early rehabilitation	Change in the rate of patients with early rehabilitation: standing, wheelchair, physiotherapy	Initiated on Day 1
The length of time spent in hospital	Reduction in the length of hospitalization between the control arm and the experimental arm. The analysis metric is the final value.	Duration of hospital stay assessed up to 15 days or hospital discharge
Evaluation of the E Satis MSO FNAH score	Improvement of the E-Satis MSO (medical-surgery-obstetrics) FNAH (French National Authority for Health) score. E-Satis is expressed out of 100. Score close to 100: positive experience	Day 15 (or hospital discharge)
Evaluation of the Mc Gill Pain score (SF-MPQ-2)	Improvement in Mc Gill Pain score (SF-MPQ-2). The McGill Pain Index is a self-assessment scale that describes the quality and intensity of pain from 0 to 50. A score close to 50 indicates extremely severe pain.	Day 1, day 15 (or hospital discharge), 1 month and 3 months

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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)

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