Optimal Analgesia for Forefoot Surgery

Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies

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

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus; Conduction Block
• Intervention / Treatment: Procedure: Ankle block; Procedure: Sham metatarsal block; Procedure: Metatarsal block; Procedure: Sham ankle block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A Stimpson, MBChB; Phone Number: 3583 +44 (01553) 613613; Email: james.stimpson@qehkl.nhs.uk

Study Locations

• United Kingdom
  • Norfolk
    • King's Lynn, Norfolk, United Kingdom, PE304ET
      • Recruiting
      • Queen Elizabeth Hospital NHS Trust
      • Contact: James A Stimpson, MBChB; Phone Number: 3583 01553613613; Email: jamesstimpson@btinternet.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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: Metatarsal block; A metatarsal block will be performed using a standardised technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static pain score	Visual Analogue scores	6 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic pain scores	Visual Analogue scores	6 hours post-operatively
Dynamic pain scores	Visual Analogue scores	Day 1 post-operatively
Dynamic pain scores	Visual Analogue scores	Day 7 post-operatively
Assessment of functional recovery	Using Functional Recovery Index	6 hours post-operatively
Assessment of functional recovery	Using Functional Recovery Index	Day 1 post-operatively
Assessment of functional recovery	Using Functional Recovery Index	Day 7 post-operatively
Static pain score	Visual Analogue scores	Day 1 post-operatively
Static pain score	Visual Analogue scores	Day 7 post-operatively

Collaborators and Investigators

• Sponsor: Queen Elizabeth Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: JSCP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No