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Medial Forefoot Block for Analgesia After Foot Surgery

Sponsor
Hull University Teaching Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01445249
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
24
Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Landmark guided ankle block.
  • Procedure: PNS guided block.
 N/A

Detailed Description

More extensive description not desired.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Landmark guided ankle block

This group will receive a landmark guided ankle block.

Procedure: Landmark guided ankle block.
25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
Other Names:
  • Other names not required

    		•
    Active Comparator: This group will be given a PNS guided ankle block

    Peripheral nerve stimulation will be used in this group to guide local anaesthetic infiltration. The technique is termed medial forefoot block.

    Procedure: PNS guided block.
    This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
    Other Names:
  • Other names not required

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of local anaesthetic block. [Over ninety minutes from the start of the study.]

      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

    1. Intravenous opiate usage following surgery [24 hours following surgery]

      The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Fit adults requiring forefoot surgery with bone cutting
    Exclusion Criteria:

    • Morbid obesity (BMI > 40)

    • Known contraindications to regional anaesthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Castle Hill Hospital. Castle Road, Cottingham, Hull East Yorkshire United Kingdom HU16 5JQ

    Sponsors and Collaborators

    • Hull University Teaching Hospitals NHS Trust

    Investigators

    • Principal Investigator: Andrew J Coe, MbChB FRCA, Hull and East Yorks NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hull University Teaching Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT01445249
    Other Study ID Numbers:
    • 07/H1304/118
    First Posted:
    Oct 3, 2011
    Last Update Posted:
    Jul 15, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Hull University Teaching Hospitals NHS Trust
    regional anaesthetic techniques
    surgery orthopaedic
    Additional relevant MeSH terms:
    Hallux Valgus

    Study Results

    No Results Posted as of Jul 15, 2019