Naropin, 0.2% Injectable Solution in Sodium chloride
DrugPreoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride
Other names: Ropivacaine 0.25%-Sodium chloride
NCT Number: NCT06534697
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride
Other names: Ropivacaine 0.25%-Sodium chloride
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%
Other names: Ropivacaine 0.25%-Dextrose 5%
Preoperative fascia iliaca block with 40 ml volume of dextrose 10%
Other names: Dextrose 10%
Time frame: 24 hours postoperatively
The total morphine consumption is measured in mg
Time frame: Up to 1 week
The percent of the number of falls reported to the number of the patients for each arm
Time frame: Up to 1 week
The duration between admision and discharge of the hospital
Contact information is provided by the study sponsor or research team.
Denisa Anastase, MD, PhD
CONTACT
Simona Florescu Cionac, MD, PhD
CONTACT
Foisor Orthopedics Clinical Hospital
Other
Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study
Acronym: FIB-PAIN
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