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NCT Number: NCT02115360

Epidural Calcitonin in Lower Limb Amputation

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.

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Key information

Conditions

Amputation Stumps Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Algharbyia, 35217, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitonin

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2014
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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