Medial Forefoot Block for Analgesia After Foot Surgery
A Randomised, Blinded Comparison of a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedJuly 15, 2019
July 1, 2019
2 years
August 17, 2011
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Over ninety minutes from the start of the study.
Secondary Outcomes (1)
Intravenous opiate usage following surgery
24 hours following surgery
Study Arms (2)
Landmark guided ankle block
ACTIVE COMPARATORThis group will receive a landmark guided ankle block.
This group will be given a PNS guided ankle block
ACTIVE COMPARATORPeripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block.
Interventions
25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
Eligibility Criteria
You may qualify if:
- Fit adults requiring forefoot surgery with bone cutting
You may not qualify if:
- Morbid obesity (BMI \> 40)
- Known contraindications to regional anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Castle Hill Hospital. Castle Road, Cottingham,
Hull, East Yorkshire, HU16 5JQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Coe, MbChB FRCA
Hull and East Yorks NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
October 3, 2011
Study Start
March 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 15, 2019
Record last verified: 2019-07