Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.

NCT02089932 | Completed Phase 4 DMC

• 1 other identifier: N-60-2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Dexmedetomidine; Femoral Nerve Block; Arthroscopic Knee Surgery

Keywords

femoral nerve block; peri-neural dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• duration of sensory block

  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.

  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.

Secondary Outcomes (9)

• Time to first request of postoperative rescue analgesic

  over the first postoperative 24hours

• Onset of sensory block

  up to 30 minutes after the end of injection

• Onset of motor block

  up to 30 minutes after the end of injection

• visual analogue pain scores (VAS)

  2hours post operative and for 24hours

• Richmond Agitation-Sedation Score (RASS)

  2hours post operative and for 24hours

Study Arms (4)

group B: control bupivacaine group

PLACEBO COMPARATOR

Patient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally

Drug: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block; Drug: Placebo

Group B-DEX 25 : Peri-neural Dexmedetomidine

EXPERIMENTAL

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (25 microgram) Dexmedetomidine peri-neurally

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

Group B-DEX 50:Peri-neural Dexmedetomidine

EXPERIMENTAL

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (50 microgram) Dexmedetomidine peri-neurally

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

Group B-DEX 75:Peri-neural Dexmedetomidine

EXPERIMENTAL

Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (75microgram) Dexmedetomidine peri-neurally

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

Interventions

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.

Group B-DEX 25 : Peri-neural Dexmedetomidine; Group B-DEX 50:Peri-neural Dexmedetomidine; Group B-DEX 75:Peri-neural Dexmedetomidine; group B: control bupivacaine group

Placebo DRUG

group B: control bupivacaine group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy

Cairo, 11562, Egypt

Location

Study Officials

• Mohamed Abdulatif, Professor of Anesthesia

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

EG (1)