Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-07 @ 1:57 PM
Study NCT ID:
NCT03922412
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
Status:
COMPLETED
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:
Plantar-block
Brief Summary:
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Detailed Description:
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital (6 hours after ALR).
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.
Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.
This study aims to determine the quality of deambulation following hallux valgus surgery.
Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.
Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.
Consenting patients will be randomized the day of surgery to one of those two groups :
1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.
During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.
Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital (6 hours after ALR).
Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.
Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.
Study Oversight
Has Oversight DMC:
False
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?: