Clinical trial NCT05941208: Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly
Official title: Efficacy of Continuous Fascia Iliaca Block in Hip Surgery in Elderly : a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Patients meeting the inclusion criteria were randomly assigned into two groups, the control group and the study group, by a computer-generated randomization program. All patients in both group will be informed by the study methods,aim, side effect in clear language, written consent will be taken in clear spoken and written language, All patients of both groups ,once arrived to the OR, monitor will be attached, baseline SBP, DBP,MAP,SPO2,PULSE will be recorded, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.

At the end of surgery, Goup 1 will receive continuous fascia iliaca block through 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 The control group will receive traditional analgesia including 50 mg pethidine with a maximum 6 hour interval and 1gm paracetamol as per need .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluating the postoperative analgesic effect
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ainshams U
name: Lydia E Zakhary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.