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Dexmedetomidine Addition to Fascia Iliaca Compartment Block

Primary Purpose

Children With Fracture Femur

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Fascia iliaca compartment block
Fascia iliaca block
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Children With Fracture Femur focused on measuring Fascia iliaca block, dexmetomidine, fracture femur, α2 agonist

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 2-6 years
  • American Society of Anesthesiologist physical class I and II
  • Fracture femur surgery

Exclusion Criteria:

  • known allergy to the study drugs
  • suspected coagulopathy
  • infection at the site of the block
  • neurological diseases
  • history of developmental delay

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group B

group BD

Arm Description

received 1 ml/kg bupivacaine 0.25%.

received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg

Outcomes

Primary Outcome Measures

Postoperative pain scores
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.

Secondary Outcome Measures

Vital signs
Heart rate, mean arterial pressure and oxygen saturation
Intraoperative hypotension
Intraoperative bradycardia
Postoperative sedation
Sedation score was assessed using Ramsay's sedation

Full Information

First Posted
May 14, 2012
Last Updated
March 15, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01600027
Brief Title
Dexmedetomidine Addition to Fascia Iliaca Compartment Block
Official Title
Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Fractures of the shaft of femur (FSF) are common in children, especially isolated fractures of the mid-third of the femur which are intensely painful. The pain of the fracture is thought to originate from the femoral shaft periosteum and muscle spasm from the quadriceps mechanism. Fascia iliaca compartment block FIC is easy and simple technique, there is no need for high-skill or expensive equipments. It has higher success rate in more than 90%of the children thigh procedures. Potentially dexmedetomidine has become an alternative to clonidine, it is a highly selective α2 agonist having about an 8-10 times affinity for α2 adrenergic receptors than clonidine and much less α1 effects, which is responsible for the hypnotic and analgesic effects. Perinural dexmedetomidine in combination with bupivacaine or ropivacaine enhance sensory and motor block without neurotoxicity in experimental studies.It has been reported to improve the quality of intrathecal, Epidural, and caudal anesthesia in children. Also, it is safe and effective in IV regional anesthetic and axillary block in adult. No study-up to the date -has been carried to evaluate its effect on the character of fascia iliaca compartment blocks as adjuvant to bupivacaine. The objectives of this study were designed to detect the effects of addition dexmedetomidine (Precedex- Abbot) as adjuvant to bupivacaine for fascia iliaca block on the quality of postoperative analgesia and also to determine its effects on the hemodynamics, recovery behaviors, sedation and possible side effects in children undergoing thigh surgeries (fracture femur).
Detailed Description
All the patients were premedicated with oral midazolam 0.5 mg/kg,1 hour prior to induction. General anesthesia was induced by inhaled sevoflurane. Laryngeal mask airway with appropriate-size for body weight was slipped, then an intravenous line was inserted,anesthesia was maintained with sevoflurane (Minimum Alveolar Concentration (MAC)from 1-1.5 in air/oxygen to maintain the Heart rate (HR) and mean arterial blood pressure (MAP) within 20% of their baseline values. A rescue dose of fentanyl 0.5 µg/kg was given if the MAC of sevoflurane exceeded 1.7 whereas HR and MAP exceeded 20% of their baseline values. Fascia iliaca compartment block was performed as described by Dalens et al technique. An axillary nerve block needle was inserted with an angle of 45±60º with the skin at (0.5±1cm) below the inguinal crease at the junction of the medial two-thirds and the lateral one-third of the line between the pubic tubercle and anterior superior iliac spine. The needle was advanced until the perception of two losses of resistance (pop) was noted which corresponded to the crossing of fascia lata and then fascia iliaca. Hypotension was defined as systolic arterial pressure 70 plus twice the age in years and associated with altered peripheral perfusion. Bradycardia was defined as HR below 80 beats/min. Delayed anesthetic emergence was defined as 20 min elapsing from the end of surgery to exiting the operating theater.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Fracture Femur
Keywords
Fascia iliaca block, dexmetomidine, fracture femur, α2 agonist

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
received 1 ml/kg bupivacaine 0.25%.
Arm Title
group BD
Arm Type
Active Comparator
Arm Description
received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
Fascia iliaca compartment block was performed as described by Dalens et al technique.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block
Intervention Description
Fascia iliaca compartment block was performed as described by Dalens et al technique.
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.
Time Frame
every 4 hours after surgery
Secondary Outcome Measure Information:
Title
Vital signs
Description
Heart rate, mean arterial pressure and oxygen saturation
Time Frame
before surgery, and every 20 min during surgery, and each 6 hours after surgery
Title
Intraoperative hypotension
Time Frame
for 24 hours after surgery
Title
Intraoperative bradycardia
Time Frame
for 24 hours after surgery
Title
Postoperative sedation
Description
Sedation score was assessed using Ramsay's sedation
Time Frame
every 4 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 2-6 years American Society of Anesthesiologist physical class I and II Fracture femur surgery Exclusion Criteria: known allergy to the study drugs suspected coagulopathy infection at the site of the block neurological diseases history of developmental delay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada F E l-Rahmawy, MD
Organizational Affiliation
Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

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Dexmedetomidine Addition to Fascia Iliaca Compartment Block

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