NCT Number: NCT07110857
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Not applicable
CHU de Lille- Hôpital Roger Salengro, Lille, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
Time frame: Intraoperative
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: In the first 72 hours postoperatively
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: On arrival, 1 hour later, 2 hours later, 4 hours later
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: Day 1, day 15 (or hospital discharge), 1 month and 3 months
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 month
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.
Time frame: Day 1, Day 15 (or hospital discharge)
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.
Time frame: Initiated on Day 1
Change in the rate of patients with early rehabilitation: standing, wheelchair, physiotherapy
Time frame: Duration of hospital stay assessed up to 15 days or hospital discharge
Reduction in the length of hospitalization between the control arm and the experimental arm. The analysis metric is the final value.
Time frame: Day 15 (or hospital discharge)
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
Time frame: Day 1, day 15 (or hospital discharge), 1 month and 3 months
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.
Contact information is provided by the study sponsor or research team.
Alexia EP
CONTACT
Liliane HAMMANI-BERKANI
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: BCS-ORL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
