Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly

NCT05941208 | Unknown

• 1 other identifier: Continuous Fascia iliaca block
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the analgesic effect of ultrasound-guided Continuous fascia iliaca block in very elderly patients with hip fracture after hip surgery compared to systemic analgesia . The main question\[s\] it aims to answer are:

• does continuous fascia iliaca block provide adequate post operative analgesia after hip surgery ?
• does it lower the incidence of post operative complications in old age ? Participants will receive continuous fascia iliaca block through ultrasound , introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours. Researchers will compare the study group receiving continuous fascia iliaca block to the control group receiving traditional systemic analgesia in the post operative period . to see if the analgesic effect is more effective

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Evaluating the postoperative analgesic effect

  measuring the degree of postoperative analgesia provided by continuous fascia iliaca compartement block using the Visual analogue score for pain ( 11 point scale where 0 indicates no pain, 10 indicates the worst pain imaginable )

  24 hours

Study Arms (2)

control group

NO INTERVENTION

study group

ACTIVE COMPARATOR

receiving post operative continuous fascia iliaca compartement block for 24 hours

Procedure: continuous fascia iliaca compartment block

Interventions

continuous fascia iliaca compartment block PROCEDURE

ultrasound Patients were in supine position and the puncture site was selected at 1 cm below the junction point at 1/3 of the connection of anterior superior spine and pubic tubercle. An ultrasound apparatus (Sonosite) high-frequency probe was placed in parallel to the inguinal fold to distinguish the femoral fascia and fascia iliaca, the needle was inserted with out-of-plane technique at an angle of 45° and the tip of the needle was pointed to the head. Once needle-tip placement under the fascia iliaca by hydrolocation was confirmed, the probe was rotated 90° into a longitudinal parasagittal orientation to visualize the needle tip in-plane and to track cephalad spread of the injectate under fascia iliaca, identification of the fascia iliaca plane through the linear probe and introducing epidural catheter 18 G , continuous infusion of bupivacaine 0.25% by a set rate of 7 ml per hour for 24 hours,

study group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age \> 65 years
• American Society of Anesthesiologists (ASA) physical status classification class II,III

You may not qualify if:

• age \< 65 years
• ASA IIII
• refusal of peripheral nerve block
• infection at the site of injection
• coagulopathy INR \> 1.8
• platelets count \< 50,000
• known allergy to used medications.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

• Rasappan K, Chua ITH, Tey JBL, Ho SWL. The continuous infusion fascia iliaca compartment block: a safe and effective analgesic modality in geriatric hip fracture patients. Arch Orthop Trauma Surg. 2021 Jan;141(1):29-37. doi: 10.1007/s00402-020-03450-2. Epub 2020 May 2.

  PMID: 32361955 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Lydia E Zakhary, MD

  Ainshams U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia E Zakhary, MD

CONTACT

00201222555128; lydia_zakhary@med.asu.edu.eg

samuel H Daniel, MD

CONTACT

00201224394897

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 12, 2023
• Study Start: April 9, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

EG (1)