Dexmedetomidine Addition to Fascia Iliaca Compartment Block

Children With Fracture Femur Clinical Trial

Official title:

Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600027
• Other study ID #: R 54
• Secondary ID: R-54
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2012
• Last updated: March 15, 2015
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Children With Fracture Femur
• Femoral Fractures

Intervention

Procedure:
• Fascia iliaca compartment block
Fascia iliaca compartment block was performed as described by Dalens et al technique.
• Fascia iliaca block
Fascia iliaca compartment block was performed as described by Dalens et al technique.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores	Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.	every 4 hours after surgery	Yes
Secondary	Vital signs	Heart rate, mean arterial pressure and oxygen saturation	before surgery, and every 20 min during surgery, and each 6 hours after surgery	Yes
Secondary	Intraoperative hypotension		for 24 hours after surgery	Yes
Secondary	Intraoperative bradycardia		for 24 hours after surgery	Yes
Secondary	Postoperative sedation	Sedation score was assessed using Ramsay's sedation	every 4 hours after surgery	Yes