An interventional study of Sono-guided injection and Ropivacaine injection in Anterior Cruciate Ligament Rupture and Femoral Nerve Block, sponsored by Chuncheon Sacred Heart Hospital. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Supportive care
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Chuncheon Sacred Heart Hospital is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
sono-guided injection with 20ml ropivacaine
Procedure: Sono-guided injection · Drug: Ropivacaine injection
sono-guided injection with 20ml 0.9% saline
Procedure: Sono-guided injection · Drug: Saline injection
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
postoperative pain after 24hours
VAS (Visual analog scale) measured 24 hours after operation * the unabbreviated scale title: The visual analog scale * the minimum and maximum values: 0, 10 * higher scores mean a worse outcome.
Time frame: 24hours
postoperative pain after 1, 3, 6, 12, 18, 48 hours
VAS (Visual analog scale) measured 1, 3, 6, 12, 18, 48 hours after operation * the unabbreviated scale title: The visual analog scale * the minimum and maximum values: 0, 10 * higher scores mean a worse outcome.
Time frame: 1, 3, 6, 12, 18, 48 hours
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Anterior Cruciate Ligament Injuries →
Chuncheon Sacred Heart Hospital