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Medial Forefoot Block for Analgesia After Foot Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445249
First Posted: October 3, 2011
Last Update Posted: October 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust
  Purpose
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 Intervention
Hallux Valgus Procedure: Landmark guided ankle block. Procedure: PNS guided block.

Study Type: Interventional
Study Design: 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.

Further study details as provided by Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Other names not required

Detailed Description:
More extensive description not desired.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fit adults requiring forefoot surgery with bone cutting

Exclusion Criteria:

  • Morbid obesity (BMI > 40)
  • Known contraindications to regional anaesthesia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445249


Locations
United Kingdom
Castle Hill Hospital. Castle Road, Cottingham,
Hull, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
Principal Investigator: Andrew J Coe, MbChB FRCA Hull and East Yorks NHS Trust
  More Information

Publications:
Responsible Party: Dr. Andrew J Coe, Doctor, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01445249     History of Changes
Other Study ID Numbers: 07/H1304/118
First Submitted: August 17, 2011
First Posted: October 3, 2011
Last Update Posted: October 3, 2011
Last Verified: September 2011

Keywords provided by Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust:
regional anaesthetic techniques
surgery orthopaedic

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases