CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Bupivacaine-adrenaline +2 moredrug
Likely dose
Bupivacaine-adrenaline 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02346110
NCT02346110Phase 4Completed

Comparison of the Effect of a Single Shot Saphenous Block With Plain Bupivacaine vs. Protracted Bupivacaine Mixture as a Supplement to Continuous Sciatic Catheter After Major Ankle and Foot Surgery

University of Aarhus·interventional·Posted Jan 26, 2015·Updated Feb 12, 2016

In Brief

A Phase 4 clinical trial evaluating Bupivacaine-adrenaline, Dexamethasone, and 1 other intervention for Arthrosis, Unspecified, Ankle and Foot. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. The hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.4 years ago

Interventions

Bupivacaine-adrenalinedrug

50 mg bupivacaine and 50 μg adrenalin

Dexamethasonedrug

4 mg

Sodium chlorideother

1 mL of sodium chloride solution as placebo