Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty

Not Applicable

Not yet recruiting

• Conditions: Hip Osteoarthritis
• Interventions: Drug: Naropin, 0.2% Injectable Solution in Sodium chloride; Drug: Naropin, 0.2% Injectable Solution in dextrose 5%; Drug: Dextrose 10 % in Water

• Registration Number: NCT06534697
• Lead Sponsor: Foisor Orthopedics Clinical Hospital

Brief Summary

This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:

·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?

The secondary questions are:

* What is the length of stay in hospital for each group?

* What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.

Detailed Description

The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.

Study Timeline

• Study Start: 2024-07-22
• Study First Submitted: 2024-07-25
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2024-12-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Indication of total primary hip arthroplasty
• ASA I-III
• BMI<40 kg/m2

Exclusion Criteria

• Inability or refusal to sign informed consent
• Known allergies to any of the drugs used in the study
• Hepatic or renal insufficiency
• Gastritis or gastroduodenal ulcer
• Opioid dependency
• Coagulopathy
• Pregnancy
• Scars in the surgery and fascia iliaca block areas
• Clinical evidence of peripheral neuropathies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naropin 0.25% in sodium chloride	Naropin, 0.2% Injectable Solution in Sodium chloride	Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride.
Naropin 0.25% in dextrose 5%	Naropin, 0.2% Injectable Solution in dextrose 5%	Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%.
Placebo	Dextrose 10 % in Water	Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%.

Primary Outcome Measures

Name	Time	Method
The total morphine consumption	24 hours postoperatively	The total morphine consumption is measured in mg

Secondary Outcome Measures

Name	Time	Method
The risk of fall	Up to 1 week	The percent of the number of falls reported to the number of the patients for each arm
Length of stay in hospital	Up to 1 week	The duration between admision and discharge of the hospital