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

NCT02128451 | Completed Phase 4 DMC

• 1 other identifier: 1350/14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Amputation Stumps

Keywords

meperdine ,fentanyl, clonidine, orthopedic surgery .

Outcome Measures

Primary Outcomes (1)

• the hemodynamic effects

  the hemodynamic parameter (heart rate and blood pressure)

  1 hour after epidural application

Secondary Outcomes (1)

• the analgesic efficacy

  24 hours

Study Arms (2)

Meperdine group

ACTIVE COMPARATOR

15ml 0.5% bupivacaine,25 mg of meperdine and 1 ml of clonidine will be injected epidurally in meperdine Group.

Drug: Meperdine

Fentanyl group

ACTIVE COMPARATOR

15ml 0.5% bupivacaine, 25 micrograms of fentanyl and 1 ml of clonidine will be injected epidurally in fentanyl Group

Drug: Fentanyl

Interventions

Meperdine DRUG

15ml 0.5% bupivacaine,25 mg of meperdine and 1 ml of clonidine will be injected epidurally in meperdine Group.

Also known as: Pethedine

Meperdine group

Fentanyl DRUG

15ml 0.5% bupivacaine, 25 micrograms of fentanyl and 1 ml of clonidine will be injected epidurally in fentanyl Group

Also known as: fenta vera

Fentanyl group

Eligibility Criteria

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

You may qualify if:

• Adults ASA I, II.
• Elective orthopedic lower limb surgery

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Faculty of Medicine ,Tanta University.

Tanta, Algharbiya, 35217, Egypt

Location

Tanta University Hospitals

Tanta, Algharbyia, 35217, Egypt

Location

Related Publications (1)

• Yousef AA, Atef AM, Awais WM. Comparison of fentanyl versus meperidine as supplements to epidural clonidine-bupivacaine in patients with lower limb orthopedic surgery under combined spinal epidural anesthesia. BMC Anesthesiol. 2015 Oct 14;15:146. doi: 10.1186/s12871-015-0126-5.

  PMID: 26468074 DERIVED

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ayman A Yousef, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: May 1, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

EG (2)