Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population

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 Overview

• Status: Recruiting
• Conditions: Regional Anesthesia Morbidity
• Intervention / Treatment: Procedure: General care; Procedure: Fascia Iliaca compartment block group; Procedure: Femoral nerve block group

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufya
    • Shibīn Al Kawm, Menoufya, Egypt, 32111
      • Recruiting
      • Menoufia university hospitails
      • Contact: Mahdy Elghanam, resident; Phone Number: +201019593180; Email: mahdyelghanam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Procedure: General care; using ordinary technique
Experimental: Group FICB; ✓ Group FICB; (30 patients) Fascia Iliaca compartment block group.	Procedure: Fascia Iliaca compartment block group; 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.
Experimental: Group FNB; ✓ Group FNB; (30 patients) Femoral nerve block group.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Assessing the Postoperative pain using The Face, Legs, Activity, Cry and Consolability (FLACC) scale.	expected within 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative need for analgesia	Postoperative need for analgesia using The visual analog scale (VAS) to evaluate the pain	expected within 6 months

Collaborators and Investigators

• Sponsor: Menoufia University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: 2/2023ANESTH58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No