Epidural Calcitonin in Lower Limb Amputation

NCT02115360 | Completed DMC

• 1 other identifier: 2308/1/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation Stumps

Keywords

epidural calcitonin; amputation; postoperative pain; Later Complication

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  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 Outcomes (1)

• Analgesic consumption

  48 hours

Other Outcomes (1)

• post amputation pain

  6 months

Study Arms (2)

Calcitonin

ACTIVE COMPARATOR

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

fentanyl

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: maicalciac

Calcitonin

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.

Also known as: fentavera

fentanyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Algharbyia, 35217, Egypt

Location

Related Publications (1)

• Knopp-Sihota JA, Newburn-Cook CV, Homik J, Cummings GG, Voaklander D. Calcitonin for treating acute and chronic pain of recent and remote osteoporotic vertebral compression fractures: a systematic review and meta-analysis. Osteoporos Int. 2012 Jan;23(1):17-38. doi: 10.1007/s00198-011-1676-0. Epub 2011 Jun 10.

  PMID: 21660557 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Calcitonin; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ayman A Yousef, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

EG (1)