Amputation Stumps Clinical Trial
Official title:
The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine Mixture in Patients With Lower Limb Orthopedic Surgery Using Combined Spinal Epidural Anesthesia
Verified date | April 2015 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
The use of clonidine as an alternative to epidural opioids offers several potential
benefits. Clonidine does not have respiratory depressant effects, and the incidence of
vomiting and pruritus is less frequent compared with that seen after administration of
epidural morphine.
Epidural clonidine have focused on the optimal doses of clonidine to be used, rather than
analyzing the potential advantage of using epidural clonidine versus opioids with respect to
efficacy and incidence of side effects.
Epidural fentanyl has been used effectively as an alternative to morphine and has been shown
to induce fewer complications when compared with epidural morphine. However, the incidence
of vomiting in patients receiving epidural fentanyl still ranges between 28% and 52%
depending on the study population and concentration used. The analgesic and side effects
profile of epidural clonidine compared with epidural fentanyl are unknown.
The primary aim of this randomized double-blind trial is to test the hypothesis that
epidural clonidine decreases the incidence of side effects compared with epidural fentanyl.
Therefore, we compared the hemodynamic effects of the epidural bupivacaine-clonidine-
fentanyl combination with those of epidural bupivacaine- clonidine- meperdine. The secondary
aim of this study was to determine the analgesic efficacy of bupivacaine-clonidine- fentanyl
combination in comparison to bupivacaine- clonidine- meperdine combination.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Adults ASA I, II. - Elective orthopedic lower limb surgery Exclusion Criteria: - Patients will be excluded from the study if their preoperative medication included opioid or non-opioid analgesics, corticosteroids, or non-steroidal anti-inflammatory drugs. Coagulation disorders, pregnancy, age less than 18 year, patient refusal, and emergency re-operation within the first 24hours also were exclusion criteria. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine ,Tanta University. | Tanta | Algharbiya |
Egypt | Tanta University Hospitals | Tanta | Algharbyia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the hemodynamic effects | the hemodynamic parameter (heart rate and blood pressure) | 1 hour after epidural application | Yes |
Secondary | the analgesic efficacy | the analgesic efficacy using visual analogue scale (VAS) | 24 hours | Yes |
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