Amputation Stumps
Conditions
Keywords
epidural calcitonin, amputation, postoperative pain, Later Complication
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.
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.
Interventions
DRUGCalcitonin
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.
DRUGFentanyl
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| post amputation pain | 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. |
Countries
Egypt
Outcome results
None listed