Perineural Dexmedetomidine and Femoral Nerve Block

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
anesthesia department
faculty of medicine
Information provided by (Responsible Party):
Abeer Ahmed, Cairo University
ClinicalTrials.gov Identifier:
NCT01964040
First received: September 26, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • onset of motor and sensory block [ Time Frame: up to 30 minutes after the end of injection ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • duration of motor block [ Time Frame: interval between time of injection and complete motor power recover ] [ Designated as safety issue: No ]
    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)".

  • Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) ( [ Time Frame: 2hours post operative and for 24hours ] [ Designated as safety issue: No ]
    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

  • time of 1st request of rescue analgesia [ Time Frame: over the poatoperative 24hours ] [ Designated as safety issue: No ]
    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"


Estimated Enrollment: 45
Study Start Date: August 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964040

Locations
Egypt
Anesthesia department-faculty of medicine-Cairo University
Cairo, Egypt, 02
Sponsors and Collaborators
Cairo University
anesthesia department
faculty of medicine
  More Information

No publications provided

Responsible Party: Abeer Ahmed, lecturer of anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT01964040     History of Changes
Other Study ID Numbers: N-38-2013
Study First Received: September 26, 2013
Last Updated: October 14, 2013
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Cairo University:
femoral nerve block
peri-neural dexmedetomidine

Additional relevant MeSH terms:
Bupivacaine
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014