Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naropin, 0.2% Injectable Solution in Sodium chloride, Naropin, 0.2% Injectable Solution in dextrose 5%, Dextrose 10 % in Water.
- Who it may be relevant to
- Registry conditions: Hip Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study
Overview
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.
Interventions
- Drug Naropin, 0.2% Injectable Solution in Sodium chloride
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride - Drug Naropin, 0.2% Injectable Solution in dextrose 5%
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5% - Drug Dextrose 10 % in Water
Preoperative fascia iliaca block with 40 ml volume of dextrose 10%
Primary outcome measures
- The total morphine consumption [Time frame: 24 hours postoperatively]
Secondary outcome measures (2)
- The risk of fall [Time frame: Up to 1 week]
- Length of stay in hospital [Time frame: Up to 1 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06534697 · 07062024