Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

NCT ID: NCT02089932

Last Updated: 2019-01-15

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-06-30

Brief Summary

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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 in different dose levels as adjuvant to local anesthetic was not previously reported for femoral nerve block.

Detailed Description

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Conditions

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Dexmedetomidine Femoral Nerve Block Arthroscopic Knee Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group B: control bupivacaine group

Patient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.

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

Placebo

Intervention Type DRUG

Group B-DEX 25 : Peri-neural Dexmedetomidine

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (25 microgram) Dexmedetomidine peri-neurally

Group Type EXPERIMENTAL

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

Intervention Type DRUG

ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.

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

Group B-DEX 50:Peri-neural Dexmedetomidine

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (50 microgram) Dexmedetomidine peri-neurally

Group Type EXPERIMENTAL

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

Intervention Type DRUG

ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.

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

Group B-DEX 75:Peri-neural Dexmedetomidine

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (75microgram) Dexmedetomidine peri-neurally

Group Type EXPERIMENTAL

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

Intervention Type DRUG

ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.

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

Interventions

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

ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery

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

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Heba Nassar,MD

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Abdulatif, Professor of Anesthesia

Role: STUDY_CHAIR

Cairo University

Locations

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Kasr Al Ainy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-60-2013

Identifier Type: -

Identifier Source: org_study_id

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