Perineural Dexmedetomidine and Femoral Nerve Block

Phase 4

• 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
• Interventions: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

• Registration Number: NCT01964040
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-26
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-14
• Last Update Submitted: 2013-10-14
• Study First Posted: 2013-10-17
• Last Update Posted: 2013-10-17
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B: control bupivacaine group	peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block	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 B-peri-DEX: Peri-neural Dexmedetomidine	peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block	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 B-sys-DEX:Systemic Dexmedetomidine	peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block	Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of this study will be the change of sensory block over time.	intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours	Over a period of 30 min after injection of the study medications, a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation (10). Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve

Secondary Outcome Measures

Name	Time	Method
onset of motor and sensory block	up to 30 minutes after the end of injection	The onset time of sensory and motor block will be: "the time elapsed between the end of injection and the development of complete block (score of 0 at all dermatomes or no movement of the quadriceps muscle.

Trial Locations

Locations (1)

Anesthesia department-faculty of medicine-Cairo University; 🇪🇬 Cairo, Egypt