Optimal Analgesia for Forefoot Surgery
Primary Purpose
Hallux Valgus, Conduction Block
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ankle block
Sham ankle block
Metatarsal block
Sham metatarsal block
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Diagnosed with 1st metatarsal pathology requiring surgical correction
- Participant meets the criteria for operative management in our day-surgery unit
Exclusion Criteria:
- Contraindication to general anaesthesia
- Diabetic neuropathy affecting lower limbs
- Peripheral neuropathy affecting lower limbs of any aetiology
- Revision surgery
- Lack of capacity to consent
Sites / Locations
- Queen Elizabeth Hospital NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ankle + Sham metatarsal
Ankle + Metatarsal
Metatarsal + sham ankle
Arm Description
Ankle block + sham metatarsal block
Ankle block + metatarsal block
Metatarsal block + sham ankle block
Outcomes
Primary Outcome Measures
Static pain score
Visual Analogue scores
Secondary Outcome Measures
Dynamic pain scores
Visual Analogue scores
Dynamic pain scores
Visual Analogue scores
Dynamic pain scores
Visual Analogue scores
Assessment of functional recovery
Using Functional Recovery Index
Assessment of functional recovery
Using Functional Recovery Index
Assessment of functional recovery
Using Functional Recovery Index
Static pain score
Visual Analogue scores
Static pain score
Visual Analogue scores
Full Information
NCT ID
NCT02637362
First Posted
December 16, 2015
Last Updated
April 27, 2018
Sponsor
Queen Elizabeth Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02637362
Brief Title
Optimal Analgesia for Forefoot Surgery
Official Title
Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Elizabeth Hospital NHS Foundation Trust
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
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.
Detailed Description
Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.
The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Conduction Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ankle + Sham metatarsal
Arm Type
Active Comparator
Arm Description
Ankle block + sham metatarsal block
Arm Title
Ankle + Metatarsal
Arm Type
Active Comparator
Arm Description
Ankle block + metatarsal block
Arm Title
Metatarsal + sham ankle
Arm Type
Active Comparator
Arm Description
Metatarsal block + sham ankle block
Intervention Type
Procedure
Intervention Name(s)
Ankle block
Intervention Description
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
Intervention Type
Procedure
Intervention Name(s)
Sham ankle block
Intervention Description
In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.
Intervention Type
Procedure
Intervention Name(s)
Metatarsal block
Intervention Description
A metatarsal block will be performed using a standardised technique
Intervention Type
Procedure
Intervention Name(s)
Sham metatarsal block
Intervention Description
In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.
Primary Outcome Measure Information:
Title
Static pain score
Description
Visual Analogue scores
Time Frame
6 hours post-operatively
Secondary Outcome Measure Information:
Title
Dynamic pain scores
Description
Visual Analogue scores
Time Frame
6 hours post-operatively
Title
Dynamic pain scores
Description
Visual Analogue scores
Time Frame
Day 1 post-operatively
Title
Dynamic pain scores
Description
Visual Analogue scores
Time Frame
Day 7 post-operatively
Title
Assessment of functional recovery
Description
Using Functional Recovery Index
Time Frame
6 hours post-operatively
Title
Assessment of functional recovery
Description
Using Functional Recovery Index
Time Frame
Day 1 post-operatively
Title
Assessment of functional recovery
Description
Using Functional Recovery Index
Time Frame
Day 7 post-operatively
Title
Static pain score
Description
Visual Analogue scores
Time Frame
Day 1 post-operatively
Title
Static pain score
Description
Visual Analogue scores
Time Frame
Day 7 post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is willing and able to give informed consent for participation in the study.
Male or female, aged 18 years or above.
Diagnosed with 1st metatarsal pathology requiring surgical correction
Participant meets the criteria for operative management in our day-surgery unit
Exclusion Criteria:
Contraindication to general anaesthesia
Diabetic neuropathy affecting lower limbs
Peripheral neuropathy affecting lower limbs of any aetiology
Revision surgery
Lack of capacity to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James A Stimpson, MBChB
Phone
+44 (01553) 613613
Ext
3583
Email
james.stimpson@qehkl.nhs.uk
Facility Information:
Facility Name
Queen Elizabeth Hospital NHS Trust
City
King's Lynn
State/Province
Norfolk
ZIP/Postal Code
PE304ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James A Stimpson, MBChB
Phone
01553613613
Ext
3583
Email
jamesstimpson@btinternet.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Analgesia for Forefoot Surgery
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