Optimal Analgesia Following Metatarsal Surgery: A Prospective Randomised, Single-Blind Sham-Controlled Trial of Three Strategies
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Static pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Static pain score
Time Frame: 6 hours post-operatively
Visual Analogue scores
Secondary Outcomes
- Assessment of functional recovery(Day 7 post-operatively)
- Dynamic pain scores(Day 7 post-operatively)
- Static pain score(Day 7 post-operatively)
Investigators
Dr James Stimpson
Consultant Anaesthetist
Queen Elizabeth Hospital NHS Foundation Trust