Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty

NCT06534697 | Not Yet Recruiting

• 1 other identifier: 07062024
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Osteoarthritis

Keywords

Fascia iliaca block; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• The total morphine consumption

  The total morphine consumption is measured in mg

  24 hours postoperatively

Secondary Outcomes (2)

• The risk of fall

  Up to 1 week

• Length of stay in hospital

  Up to 1 week

Study Arms (3)

Naropin 0.25% in sodium chloride

ACTIVE COMPARATOR

Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride.

Drug: Naropin, 0.2% Injectable Solution in Sodium chloride

Naropin 0.25% in dextrose 5%

ACTIVE COMPARATOR

Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%.

Drug: Naropin, 0.2% Injectable Solution in dextrose 5%

Placebo

PLACEBO COMPARATOR

Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%.

Drug: Dextrose 10 % in Water

Interventions

Naropin, 0.2% Injectable Solution in Sodium chloride DRUG

Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride

Also known as: Ropivacaine 0.25%-Sodium chloride

Naropin 0.25% in sodium chloride

Naropin, 0.2% Injectable Solution in dextrose 5% DRUG

Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%

Also known as: Ropivacaine 0.25%-Dextrose 5%

Naropin 0.25% in dextrose 5%

Dextrose 10 % in Water DRUG

Preoperative fascia iliaca block with 40 ml volume of dextrose 10%

Also known as: Dextrose 10%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foisor Orthopedics Clinical Hospital: lead

Related Publications (4)

• 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.

  PMID: 28059869 BACKGROUND

• 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.

  PMID: 23558369 BACKGROUND

• 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.

  PMID: 34046305 BACKGROUND

• 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.

  PMID: 38956469 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride; Glucose; Water

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Denisa Anastase, MD, PhD

  Foisor OCH

  PRINCIPAL INVESTIGATOR

• Simona Anastase, MD, PhD

  Foisor OCH

  STUDY DIRECTOR

Central Study Contacts

Denisa Anastase, MD, PhD

CONTACT

0040721255339; danastase1@gmail.com

Simona Florescu Cionac, MD, PhD

CONTACT

0040722381861; florescut@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of anesthesiology and Intensive Care

Model Details: All enrolled patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators randomly define three patient groups using the envelope method: 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 administration of morphine is according to our hospital protocol. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the second goal was length of stay and the risk of falls.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 2, 2024
• Study Start: July 22, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share