Dexmedetomidine Addition to Fascia Iliaca Compartment Block

NCT01600027 | Completed Phase 1 DMC

• 2 other identifiers: R 54R-54
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Children With Fracture Femur

Keywords

Fascia iliaca block; dexmetomidine; fracture femur; α2 agonist

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores

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

  every 4 hours after surgery

Secondary Outcomes (4)

• Vital signs

  before surgery, and every 20 min during surgery, and each 6 hours after surgery

• Intraoperative hypotension

  for 24 hours after surgery

• Intraoperative bradycardia

  for 24 hours after surgery

• Postoperative sedation

  every 4 hours after surgery

Study Arms (2)

Group B

PLACEBO COMPARATOR

received 1 ml/kg bupivacaine 0.25%.

Procedure: Fascia iliaca compartment block

group BD

ACTIVE COMPARATOR

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

Procedure: Fascia iliaca block

Interventions

Fascia iliaca compartment block PROCEDURE

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

Group B

Fascia iliaca block PROCEDURE

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

group BD

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Ghada F E l-Rahmawy, MD

  Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

EG (1)