Perineural Dexmedetomidine and Femoral Nerve Block

Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

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.

Study Overview

• Status: Unknown
• 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
• Intervention / Treatment: Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Anesthesia department-faculty of medicine-Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: 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: 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	Drug: 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: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset of motor and sensory block	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.	up to 30 minutes after the end of injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of motor block	The duration of motor block will be defined as: "the time interval between the end of injection and the complete recovery of motor power of the quadriceps muscle)".	interval between time of injection and complete motor power recover
Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) (	Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) (12) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively	2hours post operative and for 24hours
time of 1st request of rescue analgesia	The time to the first request of rescue postoperative analgesic will be: "the time interval between the onset of successful sensory block and the first request to postoperative analgesia"	over the poatoperative 24hours

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: anesthesia department; Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Estimate): October 17, 2013
• Last Update Submitted That Met QC Criteria: October 14, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: femoral nerve block; peri-neural dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: N-38-2013