Epidural Calcitonin in Lower Limb Amputation

What Was Tested

This registered not phased trial tested Calcitonin.

A prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study.

Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

It had two arms (groups): Calcitonin (active comparator) and fentanyl (active comparator).

The registry classes the interventions as drug.

More on the Plan

A cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders. Physical status American Society of Anaesthesiologist (ASA) I and II. Will undergo lower limb amputation.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of pituitary gland dysfunction; cardiac disease; chronic obstructive respiratory disease.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Calcitonin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Calcitonin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-04 with completion listed for 2016-08.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: visual analogue scale (time frame: 48 hours).

It also tracked 1 secondary outcome, for example Analgesic consumption.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Calcitonin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, all human trials.