- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03922412
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery (Plantar-block)
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
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 :
- 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).
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 :
- 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).
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabien SWISSER, MD
- Phone Number: 00334 67 33 86 61
- Email: f-swisser@chu-montpellier.fr
Study Contact Backup
- Name: Sophie BRINGUIER
- Phone Number: 00334 67 33 86 61
- Email: s-bringuierbranchereau@chu-montpellier.fr
Study Locations
-
-
-
Montpellier, France, 34000
- UH Montpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 75 years old
- patient covered by social health insurance
- have signed written informed consent
- scheduled for hallux valgus ambulatory surgery
Exclusion Criteria:
- protected patients or patients incapable of giving written informed consent
- pregnant or breastfeeding woman
- vulnerable adult
- inability to participate in pain scoring scales
- severe coagulopathy
- allergy or contraindications to study drugs
- preoperative gait disorders
- chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockcroft and Gault formula)
- severe chronic liver disease
- chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
- peripheral neuropathy
- intervention under general anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: plantar block
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).
|
|
Active Comparator: Sciatic popliteal block
Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
|
1-Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of ropivacaine 0,5% (100mg) with 2mg (0,5 ml) of dexamethasone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of steps walking ability assessed by GAITRITE Test
Time Frame: 6 hours after ALR
|
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block
|
6 hours after ALR
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity of postoperative rescue analgesics taken
Time Frame: up to 3 days after surgery
|
Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients
|
up to 3 days after surgery
|
Assessment of the quality of the sensory blocks
Time Frame: during the surgery
|
Comparison of the sensory territories of anesthesia using cold between each group
|
during the surgery
|
Assessment of the patient hospitalisation duration
Time Frame: up to 3 days after surgery
|
Comparison of the duration of hospitalization between each group
|
up to 3 days after surgery
|
Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional
Time Frame: up to 3 days after surgery
|
Comparison of overall patient satisfaction between each group
|
up to 3 days after surgery
|
Assessment of sleep quality Assessment of patient sleep quality
Time Frame: up to 3 days after surgery
|
Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group
|
up to 3 days after surgery
|
Efficacity of patient walking ability
Time Frame: up to 3 days after surgery
|
Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block
|
up to 3 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL18_0489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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