Epidural Calcitonin in Lower Limb Amputation

August 29, 2016 updated by: Ayman Abd Al-maksoud Yousef, Tanta University

The Pre-emptive Value of Epidural Calcitonin in Patients With Lower Limb Amputation. A Double Blinded Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Algharbyia
      • Tanta, Algharbyia, Egypt, 35217
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of pituitary gland dysfunction
  • cardiac disease
  • chronic obstructive respiratory disease

  • contraindications to performing an epidural block such as:

    • coagulation abnormalities
    • spinal deformities, and
  • patients allergic to local anesthetics and or calcitonin will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcitonin
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 100 iu of calcitonin will be injected epidurally in Bupivacain-Calcitonin-fentanyl (BC) Group,
Drug: Calcitonin
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Other Names:
  • maicalciac
Active Comparator: fentanyl
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Drug: Fentanyl
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Other Names:
  • fentavera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 48 hours
The primary outcome of the study the analgesic effects of epidural calcitonin versus opioids administered for patients undergoing lower limb amputation surgery on postoperative pain using combined spinal epidural anesthesia.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: 48 hours
The secondary outcome of this study is to measure analgesic consumption in patients undergoing lower limb amputation using combined spinal epidural anesthesia.
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post amputation pain
Time Frame: 6 months
the development of post amputation phantom limb pain in calcitonin versus opioids administered for patients undergoing lower limb amputation surgery on postoperative pain using combined spinal epidural anesthesia.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 13, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2308/1/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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