Epidural Calcitonin in Lower Limb Amputation

Tanta University

Status: Completed

Conditions: Amputation Stumps

Treatments: Drug: Fentanyl; Drug: Calcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02115360

2308/1/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Calcitonin

Active Comparator group

Description:

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,

Treatment:

Drug: Calcitonin

fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl