Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty (FIB-PAIN)

Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Drug: Naropin, 0.2% Injectable Solution in Sodium chloride; Drug: Naropin, 0.2% Injectable Solution in dextrose 5%; Drug: Dextrose 10 % in Water

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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denisa Anastase, MD, PhD; Phone Number: 0040721255339; Email: danastase1@gmail.com
• Study Contact Backup: Name: Simona Florescu Cionac, MD, PhD; Phone Number: 0040722381861; Email: florescut@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naropin 0.25% in sodium chloride; Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride.	Drug: Naropin, 0.2% Injectable Solution in Sodium chloride; Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride; Other Names: Ropivacaine 0.25%-Sodium chloride
Active Comparator: Naropin 0.25% in dextrose 5%; Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%.	Drug: Naropin, 0.2% Injectable Solution in dextrose 5%; Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%; Other Names: Ropivacaine 0.25%-Dextrose 5%
Placebo Comparator: Placebo; Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%.	Drug: Dextrose 10 % in Water; Preoperative fascia iliaca block with 40 ml volume of dextrose 10%; Other Names: Dextrose 10%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total morphine consumption	The total morphine consumption is measured in mg	24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Foisor Orthopedics Clinical Hospital
• Investigators: Principal Investigator: Denisa Anastase, MD, PhD, Foisor OCH; Study Director: Simona Anastase, MD, PhD, Foisor OCH

Publications and helpful links

General Publications

• Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.
• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
• Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
• Cui X, Cheng Z, Zhang T, Xu H, Luan H, Feng J, Zhang X, Zhu P. Effect of pericapsular nerve group block and suprainguinal fascia iliaca block on postoperative analgesia and stress response in elderly patients undergoing hip arthroplasty: a prospective randomized controlled double-blind trial. BMC Anesthesiol. 2024 Jul 2;24(1):220. doi: 10.1186/s12871-024-02604-8.

Study record dates

Study Major Dates

• Study Start (Estimated): July 22, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative pain; Fascia iliaca block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 07062024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No