Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597479
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2012-05-07
Brief Title:
Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Effectiveness of Distal Peripheral Nerve Blocks on Postoperative Pain Management After Ambulatory Thumb Resection Arthroplasty
Status:
COMPLETED
Status Verified Date:
2016-01
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 aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve blocks on target nerves radial and median nerve blocks at the elbow using low volume and low concentration of long acting local anesthetic provide better postoperative pain control compare with systemic analgesia alone after thumb resection arthroplasty TRA due to a prolonged selective sensitive block on the tissue trauma
Detailed Description:
We designed a prospective randomized controlled trial with nursing blinded evaluation
We enrolled 52 patients scheduled for elective ambulatory TRA 2 patients were excluded after randomization Patients were randomized into two groups
A Group A no distal peripheral nerve blocks no dPNBs group n 24 We performed usual anesthetic technique for surgery an AXILLARY BRAQUIAL PLEXUS BLOCK using SHORT ACTING local anesthetic mepivacaine 1 Patients allocated in this group didnt received any additional intervention in the postoperative period
B Group B dPNBs group n 26 We performed the same anesthetic technique for surgery AXILLARY BLOCK with 1 of mepivacaine with an additional intervention Patients allocated in this group received postoperatively dPNBs on target nerves Based on surgical approached and technique we evaluated that radial and median nerves were responsible for the innervation of the surgical area and therefore responsible for the postoperative pain We performed dPNBs ON RADIAL AND MEDIAN NERVES TARGET NERVES WITH LONG ACTING AND LOW CONCENTRATION LOCAL ANESTHETIC 0125 levobupivacaine 5mlnerve
All blocks were performed under ultrasound guidance
Analgesic regime prescribed at discharge was the same in both groups dexketoprofen with tramadol for rescue analgesia
The primary outcome was to evaluate the proportion of patients experienced moderate to severe pain during first and second day postoperatively mesured using a numerical visual scale NVS of 0 to 10 0 no pain and 10 worst pain imaginable We defined mild pain NVS 0-3 moderate pain NVS 7-10 and severe pain NVS 7-10
We considered dPNBs effective when patients experienced mild pain NVS 0-3 for at least 6 hours after dPNBs puncture
Secondary outcomes included
1 Maximum pain intensity during first and second day postoperatively
2 Duration of dPNBs defined as the interval between dPNBs performance and the occurrence of first pain
3 Time to discharge defined as the interval since patient arrived at postoperative care unit PACU until discharge home
4 Presence of distal hand motor block after dPNBs puncture
5 Needed for rescue analgesia and total consumption of tramadol during first and second day postoperatively
6 Incidence of postoperative nausea and vomiting during 1st and 2nd day postoperatively
7 Needed for rescue antiemetic therapy total consumption of ondansetron and effectiveness of treatment during 1st and 2nd day postoperatively
Patients were contacted by phone first and second day postoperatively from a blinded PACU nursing staff all outcome data were collected by PACU nursing staff blinded to group allocation
We enrolled 52 patients scheduled for elective ambulatory TRA 2 patients were excluded after randomization Patients were randomized into two groups
A Group A no distal peripheral nerve blocks no dPNBs group n 24 We performed usual anesthetic technique for surgery an AXILLARY BRAQUIAL PLEXUS BLOCK using SHORT ACTING local anesthetic mepivacaine 1 Patients allocated in this group didnt received any additional intervention in the postoperative period
B Group B dPNBs group n 26 We performed the same anesthetic technique for surgery AXILLARY BLOCK with 1 of mepivacaine with an additional intervention Patients allocated in this group received postoperatively dPNBs on target nerves Based on surgical approached and technique we evaluated that radial and median nerves were responsible for the innervation of the surgical area and therefore responsible for the postoperative pain We performed dPNBs ON RADIAL AND MEDIAN NERVES TARGET NERVES WITH LONG ACTING AND LOW CONCENTRATION LOCAL ANESTHETIC 0125 levobupivacaine 5mlnerve
All blocks were performed under ultrasound guidance
Analgesic regime prescribed at discharge was the same in both groups dexketoprofen with tramadol for rescue analgesia
The primary outcome was to evaluate the proportion of patients experienced moderate to severe pain during first and second day postoperatively mesured using a numerical visual scale NVS of 0 to 10 0 no pain and 10 worst pain imaginable We defined mild pain NVS 0-3 moderate pain NVS 7-10 and severe pain NVS 7-10
We considered dPNBs effective when patients experienced mild pain NVS 0-3 for at least 6 hours after dPNBs puncture
Secondary outcomes included
1 Maximum pain intensity during first and second day postoperatively
2 Duration of dPNBs defined as the interval between dPNBs performance and the occurrence of first pain
3 Time to discharge defined as the interval since patient arrived at postoperative care unit PACU until discharge home
4 Presence of distal hand motor block after dPNBs puncture
5 Needed for rescue analgesia and total consumption of tramadol during first and second day postoperatively
6 Incidence of postoperative nausea and vomiting during 1st and 2nd day postoperatively
7 Needed for rescue antiemetic therapy total consumption of ondansetron and effectiveness of treatment during 1st and 2nd day postoperatively
Patients were contacted by phone first and second day postoperatively from a blinded PACU nursing staff all outcome data were collected by PACU nursing staff blinded to group allocation
Study Oversight
Has Oversight DMC:
None
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?:
None