Children With Fracture FemurPhase 1NCT01600027
Dexmedetomidine Addition to Fascia Iliaca Compartment Block
A Phase 1 study testing Fascia iliaca compartment block and Fascia iliaca block in people with Children With Fracture Femur, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Children With Fracture Femur
- What is being tested?
- Fascia iliaca compartment block and Fascia iliaca block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2-6 years
- American Society of Anesthesiologist physical class I and II
- Fracture femur surgery
Who cannot join
- known allergy to the study drugs
- suspected coagulopathy
- infection at the site of the block
- neurological diseases
- history of developmental delay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery
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).
Read the 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.
- Conditions
- Children With Fracture Femur
- Being tested
- Fascia iliaca compartment block, Fascia iliaca block
- Keywords
- Fascia iliaca block, dexmetomidine, fracture femur, α2 agonist
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockProcedure or surgery
Fascia iliaca compartment block was performed as described by Dalens et al technique.
Fascia iliaca blockProcedure or surgery
Fascia iliaca compartment block was performed as described by Dalens et al technique.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Placebo comparator | received 1 ml/kg bupivacaine 0.25%. Receives: Procedure: Fascia iliaca compartment block |
| group BD | Active comparator | received 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg Receives: Procedure: Fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.
Measured: every 4 hours after surgery
Secondary outcomes (4)
Vital signs
Heart rate, mean arterial pressure and oxygen saturation
Measured: before surgery, and every 20 min during surgery, and each 6 hours after surgery
Intraoperative hypotension
Measured: for 24 hours after surgery
Intraoperative bradycardia
Measured: for 24 hours after surgery
Postoperative sedation
Sedation score was assessed using Ramsay's sedation
Measured: every 4 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Fracture FemurStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
- Investigators
- Ghada F E l-Rahmawy, MD, Principal investigator, Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600027
- Sponsor's protocol ID
- R 54
- Other IDs
- R-54
- Status last verified
- Mar 2015
- First submitted
- 14 May 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine Addition to Bupivacaine on the Quality of Fascia Iliaca Compartment Block (FICB) in Children Undergoing Femur Fracture Surgery
- ClinicalTrials.gov ID
- NCT01600027
- Acronym / sponsor ID
- R 54
- Conditions
- Children With Fracture Femur
- Keywords
- Fascia iliaca block, dexmetomidine, fracture femur, α2 agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Placebo comparator | Procedure: Fascia iliaca compartment blockreceived 1 ml/kg bupivacaine 0.25%. |
| group BD | Active comparator | Procedure: Fascia iliaca blockreceived 1 ml/kg bupivacaine 0.25% with dexmedetomidine 2 μg/kg |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 2-6 years
- American Society of Anesthesiologist physical class I and II
- Fracture femur surgery
Key exclusion criteria (5 listed)
- known allergy to the study drugs
- suspected coagulopathy
- infection at the site of the block
- neurological diseases
- history of developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia iliaca compartment blockFascia iliaca compartment block was performed as described by Dalens et al technique. | Procedure or surgery | Group B |
| Fascia iliaca blockFascia iliaca compartment block was performed as described by Dalens et al technique. | Procedure or surgery | group BD |
Primary outcome
Postoperative pain scores
Time frame: every 4 hours after surgery
Postoperative using the Objective Pain Scale (children <6 yr) which described by Hannallah et al.
4 secondary outcomes
Vital signs
Time frame: before surgery, and every 20 min during surgery, and each 6 hours after surgery
Intraoperative hypotension
Time frame: for 24 hours after surgery
Intraoperative bradycardia
Time frame: for 24 hours after surgery
Postoperative sedation
Time frame: every 4 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada F E l-Rahmawy, MD principal investigator
Anesthesia and Surgical ICU, College of Medicine, Mansoura University, Mansoura City, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fascia iliaca compartment block and Fascia iliaca block in people with Children With Fracture Femur, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: every 4 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.