NCT07597317

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Fascia Iliaca Compartment BlockAnagesiaHip FracturePostoperative PainPeripheral Nerve BlcokFemoral Nerve

Outcome Measures

Primary Outcomes (1)

  • Pain score during positioning for spinal anesthesia

    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.

    During spinal anesthesia positioning (approximately 10-15 minutes after nerve block)

Secondary Outcomes (4)

  • Pain score before nerve block

    Immediately before nerve block administration

  • Block effectiveness (sensory assessment)

    5-10 minutes after nerve block administration

  • Requirement of rescue analgesia

    During spinal anesthesia positioning

  • Ease/duration of spinal anesthesia positioning

    During spinal anesthesia procedure (from positioning start to successful SAB completion)

Study Arms (2)

Fascia Iliaca Compartment Block (FICB)

EXPERIMENTAL

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.

Procedure: Fascia Iliaca Compartment Block (FICB)

Femoral Nerve Block (FNB)

ACTIVE COMPARATOR

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.

Procedure: Fascia Iliaca Compartment Block (FICB)

Interventions

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.

Fascia Iliaca Compartment Block (FICB)Femoral Nerve Block (FNB)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders, age 20 to 70 years, ASA Class I and II. All cases undergoing abdominal surgery under general

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology

Lahore, Punjab Province, 61100, Pakistan

Location

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    PMID: 33529054BACKGROUND
  • 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.

    PMID: 38385910BACKGROUND
  • 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.

    RESULT

MeSH Terms

Conditions

Hip FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only masking to participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, parallel-group interventional study. Eighty hip arthroplasty patients will be allocated into two equal groups. Group A receives Fascia Iliaca Compartment Block (FICB) and Group B receives Femoral Nerve Block (FNB) using standard local anesthetic technique. All patients undergo spinal anesthesia. Primary outcome is pain during positioning for spinal anesthesia measured by Numeric Rating Scale (NRS). Both interventions are compared for analgesic efficacy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Resident

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

June 10, 2024

Primary Completion

December 9, 2024

Study Completion

December 9, 2024

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations