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Completed

NCT Number: NCT02089932

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

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Key information

Conditions

Dexmedetomidine Arthroscopic Knee Surgery Femoral Nerve Block

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasr Al Ainy

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Drug

Primary outcomes

  1. duration of sensory block

    Time frame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.

    the time interval between the onset of the sensory block and the complete resolution of normal sensation. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of normal sensation; 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. Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve.

Secondary outcomes

  1. Time to first request of postoperative rescue analgesic

    Time frame: over the first postoperative 24hours

    the time interval between the onset of successful sensory block and the first request to postoperative analgesia

  2. Onset of sensory block

    Time frame: up to 30 minutes after the end of injection

    the time elapsed between the end of injection and the development of complete sensory block

  3. Onset of motor block

    Time frame: up to 30 minutes after the end of injection

    the time elapsed between the end of injection and the development of complete motor block

  4. visual analogue pain scores (VAS)

    Time frame: 2hours post operative and for 24hours

    Visual analogue pain scores (resting and dynamic VAS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.

  5. Richmond Agitation-Sedation Score (RASS)

    Time frame: 2hours post operative and for 24hours

    Richmond Agitation-Sedation Score (RASS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively.

  6. duration of motor block

    Time frame: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of motor power.

    The time interval between the onset of the motor block and the complete resolution of the motor power in quadriceps muscle. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of motor power; a blinded investigator will assess the motor block using a 3-point scale where: 0 ═ no movement, 1 ═ reduced motor strength, but some perceptible movement, and 2 ═ normal motor function.

  7. total morphine consumption

    Time frame: The first 24 hours postoperatively

    The total dose of morphine needed by the patient postoperatively till 24 hours.

  8. perioperative hemodynamic parameters

    Time frame: will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.

    Vital signs (heart rate and arterial blood pressure) will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.

  9. incidence of side effects.

    Time frame: from the injection time till 24 hours postoperatively

    Adverse events will be defined as hypotension (a 30% decrease in systolic blood pressure in relation to the baseline value), bradycardia (heart rate less than 60 beats per minute), desaturation (SpO2 < 90% on room air) and postoperative nausea and/or vomiting.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effects of Different Dose Levels of Peri-neural Dexmedetomidine on the Pharmacodynamic and Side Effects Profiles of Bupivacaine-induced Ultrasound-guided Femoral Nerve Block

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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