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Medial Forefoot Block for Analgesia After Foot Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Andrew J Coe, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01445249
First received: August 17, 2011
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 17, 2011
Last Updated: September 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
regional anaesthetic techniques
surgery orthopaedic

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013