NCT02637362

Optimal Analgesia for Forefoot Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Queen Elizabeth Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hallux Valgus
• Conduction Block

Interventions

Type	Name	Description
PROCEDURE	Ankle block	Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
PROCEDURE	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.
PROCEDURE	Metatarsal block	A metatarsal block will be performed using a standardised technique
PROCEDURE	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.

Timeline

• Start date: 2018-02-02
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2015-12-22
• Last updated: 2018-05-01

Locations

1 site across 1 country: United Kingdom