An interventional study of Naropin, 0.2% Injectable Solution in Sodium chloride and Naropin, 0.2% Injectable Solution in dextrose 5% in Hip Osteoarthritis, sponsored by Foisor Orthopedics Clinical Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Foisor Orthopedics Clinical Hospital · Not applicable, Interventional, and Treatment
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.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's planned enrollment of 210 is above the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Foisor Orthopedics Clinical Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride.
Drug: Naropin, 0.2% Injectable Solution in Sodium chloride
Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%.
Drug: Naropin, 0.2% Injectable Solution in dextrose 5%
Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%.
Drug: Dextrose 10 % in Water
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in sodium chloride
Also known as: Ropivacaine 0.25%-Sodium chloride
Preoperative fascia iliaca block with 40 ml volume of naropin 0,25% in dextrose 5%
Also known as: Ropivacaine 0.25%-Dextrose 5%
Preoperative fascia iliaca block with 40 ml volume of dextrose 10%
Also known as: Dextrose 10%
The total morphine consumption
The total morphine consumption is measured in mg
Time frame: 24 hours postoperatively
The risk of fall
The percent of the number of falls reported to the number of the patients for each arm
Time frame: Up to 1 week
Length of stay in hospital
The duration between admision and discharge of the hospital
Time frame: Up to 1 week
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2024; primary completion for Dec 2024, 5 months later.
Of 197 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 5 months is below that.
Counting every sponsor, half of 224 studies reached it within 29 months; a quarter within 14 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Foisor Orthopedics Clinical Hospital