Optimal Analgesia for Forefoot Surgery

Queen Elizabeth Hospital NHS Foundation Trust

Status: Unknown

Conditions: Hallux Valgus; Conduction Block

Treatments: Procedure: Sham ankle block; Procedure: Sham metatarsal block; Procedure: Ankle block; Procedure: Metatarsal block

Study type: Interventional

Funder types: Other

Identifiers

NCT02637362

JSCP1

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 3 patient groups

Ankle + Sham metatarsal

Active Comparator group

Description:

Ankle block + sham metatarsal block

Treatment:

Procedure: Sham metatarsal block

Procedure: Ankle block

Ankle + Metatarsal

Active Comparator group

Description:

Ankle block + metatarsal block

Treatment:

Procedure: Metatarsal block

Procedure: Ankle block

Metatarsal + sham ankle

Active Comparator group

Description:

Metatarsal block + sham ankle block

Treatment:

Procedure: Metatarsal block

Procedure: Sham ankle block