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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naropin 0.25% in sodium chloride | Active Comparator | Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% 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%. |
|
| Placebo | Placebo Comparator | Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naropin, 0.2% Injectable Solution in Sodium chloride | Drug | Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total morphine consumption | The total morphine consumption is measured in mg | 24 hours postoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denisa Anastase, MD, PhD | Contact | 0040721255339 | danastase1@gmail.com | |
| Simona Florescu Cionac, MD, PhD | Contact | 0040722381861 | florescut@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Denisa Anastase, MD, PhD | Foisor OCH | Principal Investigator |
| Simona Anastase, MD, PhD | Foisor OCH | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28059869 | Background | 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. | |
| 23558369 | Background |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
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|
| Naropin, 0.2% Injectable Solution in dextrose 5% | Drug | Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5% |
|
|
| Dextrose 10 % in Water | Drug | Preoperative fascia iliaca block with 40 ml volume of dextrose 10% |
|
|
| Up to 1 week |
| 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. |
| 34046305 | 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. |
| 38956469 | 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. |
| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |