Back to resultsMedial Forefoot Block for Analgesia After Foot Surgery
Primary Purpose
Hallux Valgus
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Landmark guided ankle block.
PNS guided block.
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring regional anaesthetic techniques, surgery orthopaedic
Eligibility Criteria
Inclusion Criteria:
- Fit adults requiring forefoot surgery with bone cutting
Exclusion Criteria:
- Morbid obesity (BMI > 40)
- Known contraindications to regional anaesthesia
Sites / Locations
- Castle Hill Hospital. Castle Road, Cottingham,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Landmark guided ankle block
This group will be given a PNS guided ankle block
Arm Description
This group will receive a landmark guided ankle block.
Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block.
Outcomes
Primary Outcome Measures
Efficacy of local anaesthetic block.
The number of patients in each study arm with altered sensation to cold and pin prick, together with no requirement for opiate analgesia, following surgery was recorded.
Secondary Outcome Measures
Intravenous opiate usage following surgery
The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.
Full Information
NCT ID
NCT01445249
First Posted
August 17, 2011
Last Updated
July 11, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01445249
Brief Title
Medial Forefoot Block for Analgesia After Foot Surgery
Official Title
A Randomised, Blinded Comparison of a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks are used to provide pain relief after this work. The purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). The two techniques will be compared for reliability of postoperative analgesia.
Detailed Description
More extensive description not desired.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
regional anaesthetic techniques, surgery orthopaedic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Landmark guided ankle block
Arm Type
Active Comparator
Arm Description
This group will receive a landmark guided ankle block.
Arm Title
This group will be given a PNS guided ankle block
Arm Type
Active Comparator
Arm Description
Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block.
Intervention Type
Procedure
Intervention Name(s)
Landmark guided ankle block.
Other Intervention Name(s)
Other names not required
Intervention Description
25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
Intervention Type
Procedure
Intervention Name(s)
PNS guided block.
Other Intervention Name(s)
Other names not required
Intervention Description
This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
Primary Outcome Measure Information:
Title
Efficacy of local anaesthetic block.
Description
The number of patients in each study arm with altered sensation to cold and pin prick, together with no requirement for opiate analgesia, following surgery was recorded.
Time Frame
Over ninety minutes from the start of the study.
Secondary Outcome Measure Information:
Title
Intravenous opiate usage following surgery
Description
The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.
Time Frame
24 hours following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fit adults requiring forefoot surgery with bone cutting
Exclusion Criteria:
Morbid obesity (BMI > 40)
Known contraindications to regional anaesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Coe, MbChB FRCA
Organizational Affiliation
Hull and East Yorks NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castle Hill Hospital. Castle Road, Cottingham,
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Medial Forefoot Block for Analgesia After Foot Surgery
We'll reach out to this number within 24 hrs