- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07597317
Fascia Iliaca vs Femoral Nerve Block in Hip Fracture Patients (CPTH)
Comparative Study of Fascia Iliaca Block Versus Femoral Nerve Block for Postoperative Pain Management in Hip Fractures
Hip fractures are common orthopedic injuries, especially in older adults, and surgical repair such as hip arthroplasty is often required. Effective pain control is essential in these patients to allow proper positioning for spinal anesthesia, reduce patient discomfort, and improve overall perioperative outcomes.
Two commonly used regional anesthesia techniques for pain relief in hip fracture patients are the Fascia Iliaca Compartment Block (FICB) and the Femoral Nerve Block (FNB). Both techniques aim to block pain signals from the femoral nerve and related nerves supplying the hip region. However, there is ongoing debate regarding which technique provides better analgesia during positioning for spinal anesthesia.
This study is a prospective, randomized controlled trial conducted at Central Park Teaching Hospital, Lahore. A total of 80 patients scheduled for hip arthroplasty will be enrolled and randomly divided into two equal groups. Group A will receive Fascia Iliaca Compartment Block, while Group B will receive Femoral Nerve Block. All patients will subsequently undergo spinal anesthesia as part of standard surgical care.
The primary objective of the study is to compare the effectiveness of FICB and FNB in reducing pain during patient positioning for spinal anesthesia. Pain will be measured using the Numeric Rating Scale (NRS), which is a standard 0-10 pain scoring system, assessed before the nerve block and during positioning for spinal anesthesia.
Standard monitoring will be used in all patients, including blood pressure, pulse oximetry, and electrocardiography. Both techniques will be performed using standard local anesthetic agents. Rescue analgesia will be provided if required to ensure patient safety and comfort.
Data will be analyzed using appropriate statistical methods, and pain scores will be compared between the two groups. A p-value of ≤0.05 will be considered statistically significant.
The study aims to determine which regional anesthesia technique provides superior analgesia during spinal anesthesia positioning in hip fracture patients. The findings may help improve pain management strategies, enhance patient comfort, and optimize perioperative care in orthopedic surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
Hip fractures represent a major cause of morbidity in orthopedic practice, particularly among elderly patients. Surgical management, including hemiarthroplasty or total hip arthroplasty, is frequently required to restore mobility and reduce complications associated with prolonged immobilization. Effective perioperative pain control is essential in these patients, not only to improve comfort but also to facilitate optimal positioning for neuraxial anesthesia and to reduce perioperative physiological stress responses.
Spinal anesthesia is widely preferred over general anesthesia in hip fracture surgery due to its advantages, including reduced intraoperative blood loss, lower risk of thromboembolic events, and better postoperative analgesia. However, positioning patients with acute hip fractures for spinal anesthesia is often challenging due to severe pain, which can lead to patient discomfort, hemodynamic instability, and difficulty in performing the procedure. Adequate pre-procedural analgesia is therefore essential.
Regional nerve blocks have emerged as an effective strategy for providing analgesia in hip fracture patients. Among these, the Fascia Iliaca Compartment Block (FICB) and the Femoral Nerve Block (FNB) are commonly used techniques. Both approaches aim to block sensory input from the femoral nerve and associated branches supplying the anterior thigh and hip region. Despite their widespread use, there is ongoing debate regarding their relative effectiveness, particularly in terms of pain control during positioning for spinal anesthesia.
FICB is a fascial plane block that targets the femoral nerve, lateral femoral cutaneous nerve, and occasionally the obturator nerve by depositing local anesthetic beneath the fascia iliaca. It is considered relatively easier to perform and may provide broader sensory coverage. In contrast, FNB is a more targeted nerve block that specifically anesthetizes the femoral nerve. While FNB may provide effective analgesia, its narrower coverage may limit its efficacy in certain clinical scenarios involving hip fractures.
This study is designed as a prospective, randomized, controlled clinical trial conducted at the Orthopedics Operation Theatre of Central Park Teaching Hospital, Lahore. A total of 80 patients scheduled for elective hip arthroplasty will be enrolled after meeting eligibility criteria. Participants will be randomly allocated into two equal groups using a lottery-based randomization method. Group A will receive Fascia Iliaca Compartment Block, while Group B will receive Femoral Nerve Block. All patients will subsequently undergo standard spinal anesthesia as part of routine surgical care.
Both interventions will be performed under standard aseptic conditions using established anatomical landmark techniques. A uniform local anesthetic solution will be administered in both groups to ensure comparability. Standard intraoperative monitoring, including non-invasive blood pressure, electrocardiography, and pulse oximetry, will be applied to all patients throughout the procedure.
The primary outcome measure of this study is the comparison of pain scores during positioning for spinal anesthesia between the two groups. Pain will be assessed using the Numeric Rating Scale (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Pain assessments will be recorded prior to nerve block administration and during patient positioning for spinal anesthesia.
Secondary outcomes include baseline pain scores before intervention, adequacy of sensory block assessed by pinprick and cold sensation testing, and requirement for rescue analgesia if pain exceeds acceptable thresholds. Rescue analgesia, if required, will be administered using intravenous nalbuphine in standardized doses to ensure patient comfort and safety.
Data will be collected using a structured proforma and entered into SPSS version 25 for statistical analysis. Continuous variables will be expressed as mean and standard deviation, while categorical variables will be reported as frequencies and percentages. Independent sample t-tests will be used to compare mean pain scores between groups. Chi-square tests may be applied for categorical variables where appropriate. A p-value of ≤0.05 will be considered statistically significant.
Stratified analysis will be performed based on age, gender, and body mass index to control for potential confounding factors. This will help assess the consistency of analgesic efficacy across different patient subgroups.
Ethical approval for the study has been obtained from the institutional ethics committee of Central Park Teaching Hospital, Lahore. Written informed consent will be obtained from all participants prior to enrollment. Patient confidentiality will be strictly maintained throughout the study, and participation will not interfere with standard clinical care.
The findings of this study are expected to contribute valuable evidence regarding the comparative effectiveness of Fascia Iliaca Compartment Block and Femoral Nerve Block in hip fracture patients. The results may assist anesthesiologists and orthopedic surgeons in selecting the most effective regional anesthesia technique for improving patient comfort and facilitating spinal anesthesia positioning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 61100
- Department of Anaesthesiology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders, age 20 to 70 years, ASA Class I and II. All cases undergoing abdominal surgery under general
Exclusion Criteria:
- Documented cases of allergy to the drug used in study (assessed by record).
- Documented cases with end stage liver and renal disease (ALT/ AST > 2 times normal limit or serum creatinine > 2 mg/dl).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fascia Iliaca Compartment Block (FICB)
Patients in this arm received a Fascia Iliaca Compartment Block (FICB) prior to spinal anesthesia.
The block was performed under standard aseptic precautions using the anatomical landmark technique.
After negative aspiration, 0.3 ml/kg of 1.5% lignocaine with adrenaline was injected beneath the fascia iliaca to achieve analgesia of the femoral, lateral femoral cutaneous, and obturator nerve territories.
Pain was assessed using the Numeric Rating Scale (NRS) during positioning for spinal anesthesia.
All patients then underwent standard spinal anesthesia.
|
Fascia Iliaca Compartment Block (FICB) was administered prior to spinal anesthesia under aseptic conditions using the anatomical landmark technique.
A needle was inserted below the inguinal ligament to access the fascia iliaca compartment.
After confirmation of correct placement by loss of resistance and negative aspiration, 0.3 ml/kg of 1.5% lignocaine with adrenaline was injected.
This approach aimed to block the femoral, lateral femoral cutaneous, and obturator nerves, providing broader analgesic coverage for the hip region during positioning for spinal anesthesia.
|
|
Active Comparator: Femoral Nerve Block (FNB)
Patients in this arm received a Femoral Nerve Block (FNB) before spinal anesthesia under standard aseptic conditions using anatomical landmark technique.
The femoral nerve was identified lateral to the femoral artery at the inguinal crease.
After negative aspiration, 0.3 ml/kg of 1.5% lignocaine with adrenaline was injected to achieve femoral nerve blockade.
The block provided analgesia to the anterior thigh and hip region.
Pain was assessed using the Numeric Rating Scale (NRS) during positioning for spinal anesthesia.
All patients then received standard spinal anesthesia for surgery.
|
Fascia Iliaca Compartment Block (FICB) was administered prior to spinal anesthesia under aseptic conditions using the anatomical landmark technique.
A needle was inserted below the inguinal ligament to access the fascia iliaca compartment.
After confirmation of correct placement by loss of resistance and negative aspiration, 0.3 ml/kg of 1.5% lignocaine with adrenaline was injected.
This approach aimed to block the femoral, lateral femoral cutaneous, and obturator nerves, providing broader analgesic coverage for the hip region during positioning for spinal anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score during positioning for spinal anesthesia
Time Frame: During spinal anesthesia positioning (approximately 10-15 minutes after nerve block)
|
Pain was measured using the Numeric Rating Scale (NRS) from 0-10, where 0 indicated no pain and 10 indicated worst pain.
The score was recorded during patient positioning for spinal anesthesia after administration of Fascia Iliaca Compartment Block or Femoral Nerve Block to compare analgesic effectiveness between groups.
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During spinal anesthesia positioning (approximately 10-15 minutes after nerve block)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score before nerve block
Time Frame: Immediately before nerve block administration
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Baseline pain was assessed using the Numeric Rating Scale (NRS) prior to administration of Fascia Iliaca or Femoral Nerve Block to ensure comparability between groups.
|
Immediately before nerve block administration
|
|
Block effectiveness (sensory assessment)
Time Frame: 5-10 minutes after nerve block administration
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Effectiveness of the block was assessed using pinprick and cold sensation testing over femoral nerve distribution to confirm adequate sensory blockade after FICB or FNB.
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5-10 minutes after nerve block administration
|
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Requirement of rescue analgesia
Time Frame: During spinal anesthesia positioning
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Need for rescue analgesia (intravenous nalbuphine 4 mg) was recorded if NRS score remained >4 during positioning, indicating inadequate pain control.
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During spinal anesthesia positioning
|
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Ease/duration of spinal anesthesia positioning
Time Frame: During spinal anesthesia procedure (from positioning start to successful SAB completion)
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Time required for successful positioning and completion of spinal anesthesia was recorded as an indicator of analgesic effectiveness of the block.
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During spinal anesthesia procedure (from positioning start to successful SAB completion)
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Collaborators and Investigators
Publications and helpful links
General Publications
- 3. Marzuki HN, Zahirah I, Lau MN, Kuppusamy E, Mustapha NM, Ashari A. Likert scale versus the visual analogue scale in evaluating dentofacial aesthetics: A systematic review. Australas Orthod J. 2024;40:158-68.
- Poredos P, Poredos P, Jezovnik MK, Mavric A, Leben L, Mijovski MB, Maia P, Haddad S, Fareed J. Time Course of Inflammatory and Procoagulant Markers in the Early Period After Total Hip Replacement. Clin Appl Thromb Hemost. 2021 Jan-Dec;27:1076029620985941. doi: 10.1177/1076029620985941.
- Hayashi M, Yamamoto N, Kuroda N, Kano K, Miura T, Kamimura Y, Shiroshita A. Peripheral Nerve Blocks in the Preoperative Management of Hip Fractures: A Systematic Review and Network Meta-Analysis. Ann Emerg Med. 2024 Jun;83(6):522-538. doi: 10.1016/j.annemergmed.2024.01.024. Epub 2024 Feb 22.
- 4. Lamb JN, Nix O, Al-Wizni A, West R, Pandit H. Mortality after postoperative periprosthetic fracture of the femur after hip arthroplasty in the last decade: meta-analysis of 35 cohort studies including 4841 patients. J Arthroplasty. 2022;37(2):398-405. 5. Werner M, Macke C, Gogol M, Krettek C, Liodakis E. Differences in hip fracture care in Europe: a systematic review of recent annual reports of hip fracture registries. Eur J Trauma Emergency Surg. 2022:1-4. 6. Ghimire A, Bhattarai B, Koirala S, Subedi A. Analgesia before performing subarachnoid block in the sitting position in patients with proximal femoral fracture: a comparison between fascia iliaca block and femoral nerve block. Kathmandu Univ Med J. 2015;13(50):152-5. 7. Bantie M, Mola S, Girma T, Aweke Z, Neme D, Zemedkun A. Comparing analgesic effect of intravenous fentanyl, femoral nerve block and fascia iliaca block during spinal anesthesia positioning in elective adult patients undergoing femoral fracture surgery: a randomized controlled trial. J Pain Res. 2020:3139-46. 8. Chen L, Shen Y, Liu S, Cao Y, Zhu Z. Ultrasound-guided supra-inguinal fascia Iliaca compartment block for older adults admitted to the emergency department with hip fracture: a randomized controlled, double-blind clinical trial. BMC geriatrics. 2021;21:1-8. 9. Jain N, Mathur PR, Patodi V, Singh S. A comparative study of ultrasound-guided femoral nerve block versus fascia iliaca compartment block in patients with fracture femur for reducing pain associated with positioning for subarachnoid block. Indian J Pain. 2018;32(3):150-5. 10. Rasappan K, Chua IT, Tey JB, Ho SW. The continuous infusion fascia iliaca compartment block: a safe and effective analgesic modality in geriatric hip fracture patients. Archives Orthop Trauma Surg. 2021;141:29-37.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Central Park TH
- CPMC/IRB-No/1448A (Other Identifier: Central Park Teaching Hospital, Lahore Paksitan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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