MedDataX Logo

Perineural Dexmedetomidine and Femoral Nerve Block

NCT ID: NCT01964040

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Onset and Duration of Sensory and Motor Block of Femoral Nerve, Visual Analogue Pain Scores, Time to First Request of Rescue Analgesics, Total Morphine Consumption in 24 Hours

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

femoral nerve block peri-neural dexmedetomidine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group B: control bupivacaine group

Patient in this group will receive 25 ml bupivacaine 0.5% plus 0.5 ml normal saline peri-neurally and 0.5 ml subcutaneous normal saline.

Group Type PLACEBO_COMPARATOR

peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

Intervention Type DRUG

ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.

After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia

Group B-peri-DEX: Peri-neural Dexmedetomidine

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 0.5 ml (50 microgram) Dexmedetomidine peri-neurally and 0.5 ml subcutaneous normal saline

Group Type EXPERIMENTAL

peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

Intervention Type DRUG

ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.

After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia

Group B-sys-DEX:Systemic Dexmedetomidine

Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine.

Group Type ACTIVE_COMPARATOR

peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

Intervention Type DRUG

ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.

After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.

After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients with ASA physical status I or II, scheduled for diagnostic knee arthroscopy

Exclusion Criteria

* Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

anesthesia department

AMBIG

Sponsor Role collaborator

faculty of medicine

AMBIG

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abeer Ahmed

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anesthesia department-faculty of medicine-Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-38-2013

Identifier Type: -

Identifier Source: org_study_id