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A Randomised, Prospective, Double Blinded, Placebo Controlled Trial to Determine the Efficacy of Continuous Infusion Ankle Block Compared to Standard Single Bolus Block in the Management of Postoperative Pain Following Foot and Ankle Surgery - Ankle Block Study

A Randomised, Prospective, Double Blinded, Placebo Controlled Trial to Determine the Efficacy of Continuous Infusion Ankle Block Compared to Standard Single Bolus Block in the Management of Postoperative Pain Following Foot and Ankle Surgery - Ankle Block Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-006172-35-GB
Enrollment
56
Registered
2006-04-04
Start date
2006-07-17
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any Orthopaedic condition which would require ankle or hind foot surgery under Mr. James Calder at North Hampshire Hospital, Basingstoke.

Interventions

Product Name: Bupivacaine 0.25% Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administra

Sponsors

North Hampshire Hospital NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients listed for ankle and hindfoot surgery under Mr. James Calder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Peripheral neuropathy Inability to fill in questionnaires (e.g. dementia)

Design outcomes

Primary

MeasureTime frame
Secondary Objective: We will also be assessing whether the infusion regime alters the time to mobilise, time to discharge, the supplemental oral analgesia intake and the overall patient satisfaction.;Primary end point(s): Pain relief as assessed by visual analogue scores over 72 hours post-operatively.;Main Objective: To assess pain relief in foot and ankle surgery. This will be acheived analysing the results of a randomised, prospective, double blinded, placebo controlled trail comparing the effectiveness of a single bolus peroneal and tibial nerve block against a bolus and continuous infusion peroneal and tibial nerve block in the management of post operative pain following foot and ankle surgery.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026