Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04488315
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2020-07-19
Brief Title:
Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
According to recent studies patients following craniotomy suffer more than minimal pain two-thirds of patients experienced moderate to severe pain Postoperative pain most often occurs within 48 hours after surgery Local infiltration of anesthesia is the most simple and effective analgesia However the analgesic effect only lasts for a short-time after surgery and it cannot adequately meet the needs of postoperative analgesia after craniotomy Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone Lipid microsphere is a relatively new drug delivery system It is an artificial lipid emulsion Studies have shown that dexamethasone lipid microsphere the dexamethasone palmitate emulsion D-PAL emulsion has stronger anti-inflammatory effect than dexamethasone Therefore the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None