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Completed

NCT Number: NCT01445249

Medial Forefoot Block for Analgesia After Foot 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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castle Hill Hospital. Castle Road, Cottingham,

Hull, East Yorkshire, HU16 5JQ, United Kingdom

About this study

More extensive description not desired.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fit adults requiring forefoot surgery with bone cutting

Exclusion criteria

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

Treatment and study plan

Landmark guided ankle block.

Procedure

25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.

Other names: Other names not required

PNS guided block.

Procedure

This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.

Other names: Other names not required

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2011
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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