Hip Osteoarthritis
Conditions
Keywords
Fascia iliaca block, Postoperative pain
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.
Interventions
DRUGNaropin, 0.2% Injectable Solution in Sodium chloride
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride
DRUGNaropin, 0.2% Injectable Solution in dextrose 5%
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%
DRUGDextrose 10 % in Water
Preoperative fascia iliaca block with 40 ml volume of dextrose 10%
Sponsors
Foisor Orthopedics Clinical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total morphine consumption | 24 hours postoperatively | The total morphine consumption is measured in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactDenisa Anastase, MD, PhD
Backup ContactSimona Florescu Cionac, MD, PhD
Outcome results
None listed