Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231355
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-01-21
Brief Title:
Liposomal vs Conventional Bupivacaine for Pain Control
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy A Pilot Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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 goal of this pilot study is to test the hypothesis that liposomal bupivacaine extends the duration of paravertebral block in patients undergoing radical nephrectomy achieving improved analgesia compared to conventional bupivacaine The main questions it aims to answer are
Area under curve of numeric rating scale of pain from 12 to 72 h after surgery
Cumulative opioid consumption during the period of 12 to 72 h after surgery
Area under curve of numeric rating scale of pain from 12 to 72 h after surgery
Cumulative opioid consumption during the period of 12 to 72 h after surgery
Detailed Description:
Random numbers will be generated by an independent biostatistician in a 11 ratio sealed in sequentially numbered opaque envelopes and stored by a study coordinator Only anesthesiologists who perform paravertebral block know group allocation but are not involved in other parts of the trial Patients other health-care team members and investigators for data collection and outcome assessment are masked from group assignments
Paravertebral block will be performed with either liposomal bupivacaine or plain bupivacaine The efficacy of nerve block will be assessed every 5 minutes after local anesthetic injection We will evaluate pain severity opioid consumption and occurrence of adverse events at the following timepoints ie end of surgery 30 minutes after surgery and 2 6 12 24 36 48 60 and 72 hours after surgery Additionally occurrence of complications quality of recovery and subjective sleep quality will be assessed during hospital stay after surgery
Paravertebral block will be performed with either liposomal bupivacaine or plain bupivacaine The efficacy of nerve block will be assessed every 5 minutes after local anesthetic injection We will evaluate pain severity opioid consumption and occurrence of adverse events at the following timepoints ie end of surgery 30 minutes after surgery and 2 6 12 24 36 48 60 and 72 hours after surgery Additionally occurrence of complications quality of recovery and subjective sleep quality will be assessed during hospital stay after surgery
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