NCT02637362

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

December 16, 2015

Last Update Submit

April 27, 2018

Conditions

Hallux ValgusConduction Block

Outcome Measures

Primary Outcomes (1)

  • Static pain score

    Visual Analogue scores

    6 hours post-operatively

Secondary Outcomes (8)

  • Dynamic pain scores

    6 hours post-operatively

  • Dynamic pain scores

    Day 1 post-operatively

  • Dynamic pain scores

    Day 7 post-operatively

  • Assessment of functional recovery

    6 hours post-operatively

  • Assessment of functional recovery

    Day 1 post-operatively

  • +3 more secondary outcomes

Study Arms (3)

Ankle + Sham metatarsal

ACTIVE COMPARATOR

Ankle block + sham metatarsal block

Procedure: Ankle blockProcedure: Sham metatarsal block

Ankle + Metatarsal

ACTIVE COMPARATOR

Ankle block + metatarsal block

Procedure: Ankle blockProcedure: Metatarsal block

Metatarsal + sham ankle

ACTIVE COMPARATOR

Metatarsal block + sham ankle block

Procedure: Sham ankle blockProcedure: Metatarsal block

Interventions

Ankle blockPROCEDURE

Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique

Ankle + MetatarsalAnkle + Sham metatarsal
Sham ankle blockPROCEDURE

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.

Metatarsal + sham ankle
Metatarsal blockPROCEDURE

A metatarsal block will be performed using a standardised technique

Ankle + MetatarsalMetatarsal + sham ankle
Sham metatarsal blockPROCEDURE

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.

Ankle + Sham metatarsal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to general anaesthesia
  • Diabetic neuropathy affecting lower limbs
  • Peripheral neuropathy affecting lower limbs of any aetiology
  • Revision surgery
  • Lack of capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital NHS Trust

Kings Lynn, Norfolk, PE304ET, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hallux ValgusHeart Block

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

James A Stimpson, MBChB

CONTACT

+44 (01553) 613613james.stimpson@qehkl.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

February 2, 2018

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)