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Optimal Analgesia for Forefoot Surgery

Q

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

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

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

Trial contacts and locations

1

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Central trial contact

James A Stimpson, MBChB

Data sourced from clinicaltrials.gov

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