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Optimal Analgesia for Forefoot Surgery

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ClinicalTrials.gov Identifier: NCT02637362
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr James Stimpson, Queen Elizabeth Hospital NHS Foundation Trust

Brief Summary:
A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.

Condition or disease Intervention/treatment Phase
Hallux Valgus Conduction Block Procedure: Ankle block Procedure: Sham ankle block Procedure: Metatarsal block Procedure: Sham metatarsal block Not Applicable

Detailed Description:

Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.

The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ankle + Sham metatarsal
Ankle block + sham metatarsal block
Procedure: Ankle block
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique

Procedure: Sham metatarsal block
In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.

Active Comparator: Ankle + Metatarsal
Ankle block + metatarsal block
Procedure: Ankle block
Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique

Procedure: Metatarsal block
A metatarsal block will be performed using a standardised technique

Active Comparator: Metatarsal + sham ankle
Metatarsal block + sham ankle block
Procedure: Sham ankle block
In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.

Procedure: Metatarsal block
A metatarsal block will be performed using a standardised technique




Primary Outcome Measures :
  1. Static pain score [ Time Frame: 6 hours post-operatively ]
    Visual Analogue scores


Secondary Outcome Measures :
  1. Dynamic pain scores [ Time Frame: 6 hours post-operatively ]
    Visual Analogue scores

  2. Dynamic pain scores [ Time Frame: Day 1 post-operatively ]
    Visual Analogue scores

  3. Dynamic pain scores [ Time Frame: Day 7 post-operatively ]
    Visual Analogue scores

  4. Assessment of functional recovery [ Time Frame: 6 hours post-operatively ]
    Using Functional Recovery Index

  5. Assessment of functional recovery [ Time Frame: Day 1 post-operatively ]
    Using Functional Recovery Index

  6. Assessment of functional recovery [ Time Frame: Day 7 post-operatively ]
    Using Functional Recovery Index

  7. Static pain score [ Time Frame: Day 1 post-operatively ]
    Visual Analogue scores

  8. Static pain score [ Time Frame: Day 7 post-operatively ]
    Visual Analogue scores



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or female, aged 18 years or above.
  • Diagnosed with 1st metatarsal pathology requiring surgical correction
  • Participant meets the criteria for operative management in our day-surgery unit

Exclusion Criteria:

  • Contraindication to general anaesthesia
  • Diabetic neuropathy affecting lower limbs
  • Peripheral neuropathy affecting lower limbs of any aetiology
  • Revision surgery
  • Lack of capacity to consent

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): NCT02637362


Contacts
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Contact: James A Stimpson, MBChB +44 (01553) 613613 ext 3583 james.stimpson@qehkl.nhs.uk

Locations
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United Kingdom
Queen Elizabeth Hospital NHS Trust Recruiting
King's Lynn, Norfolk, United Kingdom, PE304ET
Contact: James A Stimpson, MBChB    01553613613 ext 3583    jamesstimpson@btinternet.com   
Sponsors and Collaborators
Queen Elizabeth Hospital NHS Foundation Trust

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Responsible Party: Dr James Stimpson, Consultant Anaesthetist, Queen Elizabeth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02637362     History of Changes
Other Study ID Numbers: JSCP1
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hallux Valgus
Heart Block
Foot Deformities
Musculoskeletal Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes