ENT CancersBCS-ORLNCT07110857
Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
A study testing Cervical plexus block with 0.2 % Naropeine in people with ENT Cancers, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ENT Cancers
- What is being tested?
- Cervical plexus block with 0.2 % Naropeine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 7 sitesFrance
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHU de Lille- Hôpital Roger Salengro
Lille, 59000
Elsa JOZEFOWICZ
Elsa.jozefowicz@chu-lille.fr
Assistance publique - Hôpitaux de Marseille
Marseille, 13005
Elsa Giuly yague, PH, elsagiuly@ap-hm.fr
AP-HP - Hôpital Lariboisière
Paris, 75010
Sonia BOUKTHIR, Dr
sonia.boukthir@aphp.fr
Assistance publique - Hôpitaux de Paris
Paris, 75015
Laetitia Desplanque, laetitia.desplanque@aphp.fr
CHU Charles Nicolle
Rouen, 76000
Jean SELIM
Jean.selim@chu-rouen.fr
hôpital Foch
Suresnes, 92150
Morgan Le Guen, Pr
m.leguen@hopital-foch.com
Institut Gustave Roussy
Villejuif, 94805
Deborah TEMPESTA, Dr
Deborah.TEMPESTA@gustaveroussy.fr
About this study
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.
Read the 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.
- Conditions
- ENT Cancers
- Being tested
- Cervical plexus block with 0.2 % Naropeine, Cervical plexus block with saline placebo
- Keywords
- the superficial cervical plexus block, surgery, locoregional anesthesia, locoregional analgesia, ENT surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical plexus block with 0.2 % NaropeineProcedure or surgery
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 or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Naropeine Arm | Experimental | Superficial cervical plexus block with 0.2 % ropivacaine (Naropeine) Receives: Procedure: Cervical plexus block with 0.2 % Naropeine |
| Placebo Arm | Placebo comparator | Superficial cervical plexus block with 0.9 % saline placebo Receives: Procedure: Cervical plexus block with saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first 24 hours postoperatively
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 1, day 15 (or hospital discharge), 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT CancersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Laetitia Desplanque, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110857
- Sponsor's protocol ID
- APHP230866
- Other IDs
- PHRCI-2022-38, 2024-510942-15-00
- Acronym
- BCS-ORL
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
- ClinicalTrials.gov ID
- NCT07110857
- Acronym / sponsor ID
- BCS-ORL / APHP230866
- Conditions
- ENT Cancers
- Keywords
- the superficial cervical plexus block, surgery, locoregional anesthesia, locoregional analgesia, ENT surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naropeine Arm | Experimental | Procedure: Cervical plexus block with 0.2 % NaropeineSuperficial cervical plexus block with 0.2 % ropivacaine (Naropeine) |
| Placebo Arm | Placebo comparator | Procedure: Cervical plexus block with saline placeboSuperficial cervical plexus block with 0.9 % saline placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical plexus block with 0.2 % NaropeineUnder 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 or surgery | Naropeine Arm |
| Cervical plexus block with saline placeboUnder 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 | Procedure or surgery | Placebo Arm |
Primary outcome
Amount of morphine
Time frame: The first 24 hours postoperatively
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laetitia Desplanque principal investigator
Assistance Publique - Hôpitaux de Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical plexus block with 0.2 % Naropeine in people with ENT Cancers, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia EP (01 40 27 18 63, alexia.ep@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of morphine (time frame: The first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.