Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-25 @ 11:59 AM
Study NCT ID:
NCT03456661
Status:
TERMINATED
Last Update Posted:
2019-09-20
First Post:
2014-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
Comparison Between Levobupivacaine 0.25% and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Modified Pectoral Nerve Block, a Double Blind Randomised Controlled Trial.
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The surgical approach has changed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure.
The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .
The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.
The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .
The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.
Detailed Description:
Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block, if participants meet in- and exclusion criteria and provide written informed consent.
Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.
Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).
Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.
When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).
Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.
Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).
Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.
When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B300201421166 | REGISTRY | FAGG | View |