Medial Forefoot Block for Analgesia After Foot Surgery

July 11, 2019 updated by: Hull University Teaching Hospitals NHS Trust

A Randomised, Blinded Comparison of a Nerve Stimulator Guided Ankle Block Compared to a Landmark Guided Ankle Block for Pain Relief After Forefoot Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

More extensive description not desired.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital. Castle Road, Cottingham,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fit adults requiring forefoot surgery with bone cutting

Exclusion Criteria:

  • Morbid obesity (BMI > 40)
  • Known contraindications to regional anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of local anaesthetic block.
Time Frame: 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.
Over ninety minutes from the start of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravenous opiate usage following surgery
Time Frame: 24 hours following surgery
The usage of intravenous morphine, delivered by a ptient controlled analgesia system, in each group was recorded.
24 hours following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/H1304/118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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