Clinical Trial: Optimal Analgesia for Forefoot Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Queen Elizabeth Hospital NHS Foundation Trust

Current Primary Outcome: Static pain score [ Time Frame: 6 hours post-operatively ]

Visual Analogue scores


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dynamic pain scores [ Time Frame: 6 hours post-operatively ]
    Visual Analogue scores
  • Dynamic pain scores [ Time Frame: Day 1 post-operatively ]
    Visual Analogue scores
  • Dynamic pain scores [ Time Frame: Day 7 post-operatively ]
    Visual Analogue scores
  • Assessment of functional recovery [ Time Frame: 6 hours post-operatively ]
    Using Functional Recovery Index
  • Assessment of functional recovery [ Time Frame: Day 1 post-operatively ]
    Using Functional Recovery Index
  • Assessment of functional recovery [ Time Frame: Day 7 post-operatively ]
    Using Functional Recovery Index
  • Static pain score [ Time Frame: Day 1 post-operatively ]
    Visual Analogue scores
  • Static pain score [ Time Frame: Day 7 post-operatively ]
    Visual Analogue scores


Original Secondary Outcome: Same as current

Information By: Queen Elizabeth Hospital NHS Foundation Trust

Dates:
Date Received: December 16, 2015
Date Started: October 2016
Date Completion: June 2018
Last Updated: October 4, 2016
Last Verified: October 2016