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Amputation Stumps | The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine

Amputation Stumps research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Amputation Stumps

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Meperdine15ml 0.5% bupivacaine,25 mg of meperdine and 1 ml of clonidine will be injected epidurally in meperdine Group.

Drug:Fentanyl15ml 0.5% bupivacaine, 25 micrograms of fentanyl and 1 ml of clonidine will be injected epidurally in fentanyl Group

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Meperdine group15ml 0.5% bupivacaine,25 mg of meperdine and 1 ml of clonidine will be injected epidurally in meperdine Group.

Fentanyl group15ml 0.5% bupivacaine, 25 micrograms of fentanyl and 1 ml of clonidine will be injected epidurally in fentanyl Group

Study Status

Completed

Start Date: April 2014

Completed Date: October 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: the hemodynamic effects

Secondary Outcome: the analgesic efficacy

Study sponsors, principal investigator, and references

Principal Investigator: Ayman A Yousef, MD

Lead Sponsor: Tanta University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02128451

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