Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Quality of Recovery After Major Breast Cancer Surgery a Prospective Multicentre Randomized Triple Blinded Trial Comparing Erector Spinae Plane Block and Intravenous Lidocaine Infusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The erector spinae plane block ESPB is gaining popularity as a regional anesthetic technique for major breast cancer surgery Although there is controversy about its mechanism of action emerging evidence suggests that clinical analgesia observed after ESPB in breast surgery may be due to rapid and sustained local anesthetic absorption from the injection site Hence intravenous LA infusion IVLI during the perioperative period could offer an effective alternative to invasive ESPB
Detailed Description:
Major Breast Cancer Surgery BCS including mastectomy or modified radical mastectomy MRM is a globally prevalent procedure Unfortunately it is associated not only with significant acute postoperative pain but also a high incidence of chronic postsurgical pain 30-50 To improve outcomes regional anesthetic techniques have been explored including thoracic paravertebral block TPVB and ultrasound-guided erector spinae plane block ESPB While TPVB is considered the gold standard it carries potential complications such as pleural puncture and pneumothorax In contrast ultrasound-guided USG ESPB is gaining popularity due to its technical simplicity and safety However controversy surrounds its mechanism of action particularly the variable cutaneous sensory loss over anterior thoracic dermatomes An emerging theory suggests that ESPBs clinical analgesia results from rapid and sustained local anesthetic LA absorption from the injection site As an alternative intravenous LA infusion IVLI during the perioperative period may offer equivalent analgesia without the invasiveness of ESPB IV lidocaine known for its substantial analgesic properties persists beyond its typical duration of action likely through mechanisms beyond sodium channel blockade Although IV lidocaine has been established as part of multimodal analgesia in various perioperative settings data specific to major BCS remain scarce In this prospective multicenter randomized triple-blind trial the investigators aim to compare quality of recovery assessed using the validated Quality of Recovery 15 QoR15 score between USG ESPB and IVLI The investigators hypothesis is that the quality of recovery after major breast cancer surgery with IVLI will be comparable to that achieved with USG ESPB
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