Regional Anesthesia MorbidityNCT05882201
Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population
A study testing Fascia Iliaca compartment block group, Femoral nerve block group and General care in people with Regional Anesthesia Morbidity, run by Menoufia University at 1 site in Egypt.
Trial summary
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety. (1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Fascia Iliaca compartment block group, Femoral nerve block group and General care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Oct 2023
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients are within the age range of 5 to 12 years old.
- Isolated Traumatic fracture of the femur bone.
- ASA I or II physical status.
- Pts weighed ≥10 kg
Who cannot join
- Refusal of the patient's parents or legal guardians to give informed consent.
- History of allergy to any of the study drugs.
- Injury at the site of injection.
- Vascular compromise an injured leg.
- Bilateral femur fracture.
- Recent trauma to the head, chest, or abdomen.
Show all 10Show fewer
- history of bleeding disorder, or anticoagulant therapy.
- Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
- Neurological and/or psychological diseases.
- Associated cardio-respiratory illness.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia university hospitails
Shibīn al Kawm, Menoufya, 32111
Mahdy Elghanam, resident, +201019593180, mahdyelghanam@gmail.com
About this study
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety.
(1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone.
(10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.
Read the detailed description
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety.
(1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone.
(10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Fascia Iliaca compartment block group, Femoral nerve block group, General care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia Iliaca compartment block groupProcedure or surgery
Group FICB Fascia: with the patient supine, the skin was prepped and draped with alcohol solution 70%,
. A 22-G needle will be visualized entering the fascia Lata and the FI. bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40 ml will be injected after aspiration beneath the fascia Lata.
Femoral nerve block groupProcedure or surgery
✓ Group FNB; With the patient supine, the skin will be prepped and draped with alcohol solution 70% The nerve in the crosssection is a triangular white structure lateral to the femoral artery. Ultrasoundallows direct visualization of the needle and nerve as well as real-time monitoring of the injection of local anesthetic. An in-plane approach will be used to direct needle placement to the femoral nerve and inject after aspiration with bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40ml.
General careProcedure or surgery
using ordinary technique
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group Receives: Procedure: General care |
| Group FICB | Experimental | ✓ Group FICB; (30 patients) Fascia Iliaca compartment block group. Receives: Procedure: Fascia Iliaca compartment block group |
| Group FNB | Experimental | ✓ Group FNB; (30 patients) Femoral nerve block group. Receives: Procedure: Femoral nerve block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Assessing the Postoperative pain using The Face, Legs, Activity, Cry and Consolability (FLACC) scale.
Measured: expected within 6 months
Secondary outcomes (1)
Postoperative need for analgesia
Postoperative need for analgesia using The visual analog scale (VAS) to evaluate the pain
Measured: expected within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Menoufia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * The study will be a prospective randomized controlled study. Patients will be randomized by a computer-generated program into 3 equal parallel groups that will be randomly assigned to either: * Control group;(30 patient). * Group FICB; (30 patients) Fascia Iliaca compartment block group. * Group FNB; (30 patients) Femoral nerve block group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdy Mohamed Elghanam, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882201
- Sponsor's protocol ID
- 2/2023ANESTH58
- Status last verified
- May 2023
- First submitted
- 4 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu JP. Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. Pediatr Clin North Am. 2020 Feb;67(1):71-84. doi: 10.1016/j.pcl.2019.09.006.
PubMed 31779838
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population
- ClinicalTrials.gov ID
- NCT05882201
- Acronym / sponsor ID
- 2/2023ANESTH58
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 31 May 2023 (actual)
- 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.
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety.
(1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone.
(10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.
Detailed description
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety.
(1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone.
(10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- * The study will be a prospective randomized controlled study. Patients will be randomized by a computer-generated program into 3 equal parallel groups that will be randomly assigned to either: * Control group;(30 patient). * Group FICB; (30 patients) Fascia Iliaca compartment block group. * Group FNB; (30 patients) Femoral nerve block group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: General careControl group |
| Group FICB | Experimental | Procedure: Fascia Iliaca compartment block group✓ Group FICB; (30 patients) Fascia Iliaca compartment block group. |
| Group FNB | Experimental | Procedure: Femoral nerve block group✓ Group FNB; (30 patients) Femoral nerve block group. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All patients are within the age range of 5 to 12 years old.
- Isolated Traumatic fracture of the femur bone.
- ASA I or II physical status.
- Pts weighed ≥10 kg
Key exclusion criteria (10 listed)
- Refusal of the patient's parents or legal guardians to give informed consent.
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 block groupGroup FICB Fascia: with the patient supine, the skin was prepped and draped with alcohol solution 70%, . A 22-G needle will be visualized entering the fascia Lata and the FI. bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40 ml will be injected after aspiration beneath the fascia Lata. | Procedure or surgery | Group FICB |
| Femoral nerve block group✓ Group FNB; With the patient supine, the skin will be prepped and draped with alcohol solution 70% The nerve in the crosssection is a triangular white structure lateral to the femoral artery. Ultrasoundallows direct visualization of the needle and nerve as well as real-time monitoring of the injection of local anesthetic. An in-plane approach will be used to direct needle placement to the femoral nerve and inject after aspiration with bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40ml. | Procedure or surgery | Group FNB |
| General careusing ordinary technique | Procedure or surgery | Control group |
Primary outcome
Postoperative pain
Time frame: expected within 6 months
Assessing the Postoperative pain using The Face, Legs, Activity, Cry and Consolability (FLACC) scale.
1 secondary outcome
Postoperative need for analgesia
Time frame: expected within 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Results publication: PubMed 31779838Wu JP. Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. Pediatr Clin North Am. 2020 Feb;67(1):71-84. doi: 10.1016/j.pcl.2019.09.006.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia Iliaca compartment block group, Femoral nerve block group and General care in people with Regional Anesthesia Morbidity, run by Menoufia 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: expected within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882201, which also lists 1 linked publication.
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 31 May 2023.