Skip to content

Optimal Analgesia for Forefoot Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02637362
Enrollment
69
Registered
2015-12-22
Start date
2018-02-02
Completion date
2019-06-30
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conduction Block, Hallux Valgus

Brief summary

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

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.

Interventions

PROCEDUREAnkle block

Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique

PROCEDURESham 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.

PROCEDUREMetatarsal block

A metatarsal block will be performed using a standardised technique

PROCEDURESham 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.

Sponsors

Queen Elizabeth Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Static pain score6 hours post-operativelyVisual Analogue scores

Secondary

MeasureTime frameDescription
Dynamic pain scores6 hours post-operativelyVisual Analogue scores
Assessment of functional recovery6 hours post-operativelyUsing Functional Recovery Index
Static pain scoreDay 1 post-operativelyVisual Analogue scores

Countries

United Kingdom

Contacts

Primary ContactJames A Stimpson, MBChB
james.stimpson@qehkl.nhs.uk+44 (01553) 613613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026