Overview

This trial is active, not recruiting.

Conditions 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
Treatment peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block
Phase phase 4
Sponsor Cairo University
Collaborator anesthesia department
Start date August 2013
End date December 2013
Trial size 45 participants
Trial identifier NCT01964040, N-38-2013

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Placebo Comparator)
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.
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
(Experimental)
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
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
(Active Comparator)
Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine.
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

Primary Outcomes

Measure
The primary outcome measure of this study will be the change of sensory block over time.
time frame: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours

Secondary Outcomes

Measure
onset of motor and sensory block
time frame: up to 30 minutes after the end of injection

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Cairo University.