Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT07110857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of the Superficial Cervical Plexus Block in Oncological Throat and Neck Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCS-ORL
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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: