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Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery (Plantar-block)

Primary Purpose

Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PLANTAR BLOCK
Sciatic popliteal block
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia focused on measuring Anesthesia, plantar Block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

plantar block

Sciatic popliteal block

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of steps walking ability assessed by GAITRITE Test
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block

Secondary Outcome Measures

Quantity of postoperative rescue analgesics taken
Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients
Assessment of the quality of the sensory blocks
Comparison of the sensory territories of anesthesia using cold between each group
Assessment of the patient hospitalisation duration
Comparison of the duration of hospitalization between each group
Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional
Comparison of overall patient satisfaction between each group
Assessment of sleep quality Assessment of patient sleep quality
Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group
Efficacity of patient walking ability
Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block

Full Information

First Posted
April 11, 2019
Last Updated
March 9, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03922412
Brief Title
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery
Acronym
Plantar-block
Official Title
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
April 15, 2021 (Anticipated)
Study Completion Date
April 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
Keywords
Anesthesia, plantar Block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
plantar block
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Sciatic popliteal block
Arm Type
Active Comparator
Arm Description
Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)
Intervention Type
Procedure
Intervention Name(s)
PLANTAR BLOCK
Intervention Description
Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of mepivacain 1% (200mg) Plantar block 10 minutes later : patient in supine position. Medial midfoot injection of 5 ml of the mixture labelled " BLOC PLANTAIRE " containing 5 ml of Ropivacaine 0,5% (25mg) with 0,5 ml dexaméthasone (2mg) Distal deep fibular block : patient in supine position, injection around the dorsal foot artery of 2 ml of the mixture labelled " BLOC FIBULAIRE " containing 2 ml of Ropivacaine 0,5% (10mg).
Intervention Type
Procedure
Intervention Name(s)
Sciatic popliteal block
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of steps walking ability assessed by GAITRITE Test
Description
Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block
Time Frame
6 hours after ALR
Secondary Outcome Measure Information:
Title
Quantity of postoperative rescue analgesics taken
Description
Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients
Time Frame
up to 3 days after surgery
Title
Assessment of the quality of the sensory blocks
Description
Comparison of the sensory territories of anesthesia using cold between each group
Time Frame
during the surgery
Title
Assessment of the patient hospitalisation duration
Description
Comparison of the duration of hospitalization between each group
Time Frame
up to 3 days after surgery
Title
Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional
Description
Comparison of overall patient satisfaction between each group
Time Frame
up to 3 days after surgery
Title
Assessment of sleep quality Assessment of patient sleep quality
Description
Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group
Time Frame
up to 3 days after surgery
Title
Efficacity of patient walking ability
Description
Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block
Time Frame
up to 3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien SWISSER, MD
Phone
00334 67 33 86 61
Email
f-swisser@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie BRINGUIER
Phone
00334 67 33 86 61
Email
s-bringuierbranchereau@chu-montpellier.fr
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien SWISSER

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery

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