Optimal Analgesia for Forefoot Surgery

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637362
• Other study ID #: JSCP1
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Queen Elizabeth Hospital NHS Foundation Trust
• Contact: James A Stimpson, MBChB
• Phone: +44 (01553) 613613
• Email: james.stimpson[@]qehkl.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conduction Block
• Hallux Valgus
• Heart Block

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital NHS Trust	King's Lynn	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static pain score	Visual Analogue scores	6 hours post-operatively
Secondary	Dynamic pain scores	Visual Analogue scores	6 hours post-operatively
Secondary	Dynamic pain scores	Visual Analogue scores	Day 1 post-operatively
Secondary	Dynamic pain scores	Visual Analogue scores	Day 7 post-operatively
Secondary	Assessment of functional recovery	Using Functional Recovery Index	6 hours post-operatively
Secondary	Assessment of functional recovery	Using Functional Recovery Index	Day 1 post-operatively
Secondary	Assessment of functional recovery	Using Functional Recovery Index	Day 7 post-operatively
Secondary	Static pain score	Visual Analogue scores	Day 1 post-operatively
Secondary	Static pain score	Visual Analogue scores	Day 7 post-operatively