About this trial
The goal of this clinical trial is to learn if a new local anesthesia technique can control pain as well as the standard spinal anesthesia for adults having hip endoprosthesis surgery. The main questions it aims to answer are:
* Is the new local anesthesia technique as effective as standard spinal anesthesia in managing pain during the first two days after surgery? * Does the new technique allow participants to move their leg sooner after the operation?
Researchers will compare the new local anesthesia technique (numbing medicine injected directly around the hip joint) to standard spinal anesthesia (a numbing injection in the back) to see if the new technique works just as well for pain control while possibly causing fewer side effects like nausea.
Participants who join this study will be randomly placed into one of two groups.
One group will receive the standard spinal anesthesia before their surgery.
The other group will receive the new local anesthesia technique before their surgery.
After the operation, researchers will track the amount of extra pain medicine each participant uses and will check their ability to move their hip, knee, and foot.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form.
Scheduled for hip endoprosthesis surgery for femoral fracture with an anterior, lateral or posterolateral approach (any approach).
Age 18 years or older.
Willing and able to comply with the study protocol.
Disqualifiers
Failure to provide informed consent.
Age less than 18 years.
Known allergy to local anesthetics or other medications used in the protocol.
Presence of infection at the planned injection site.
Trial design
Parallel
Treatments tested in this trial
Pericapsular Nerve Group Blocks with Local Infiltration Analgesia
Procedure/SurgeryAn ultrasound-guided, motor-sparing regional anesthesia procedure. It involves three distinct injections: 1) An anterior Pericapsular Nerve Group (A-PENG) block targeting the sensory articular branches of the femoral and obturator nerves. 2) A Local Infiltration Analgesia (LIA) of the surgical incision line. 3) A posterior PENG (PONG) block targeting sensory branches from the sciatic plexus. The local anesthetic mixture consists of ropivacaine, mepivacaine with epinephrine, and dexamethasone in specific volumes for each injection site.
spinal anesthesia
Procedure/SurgeryStandard neuraxial anesthesia technique involving the injection of a local anesthetic into the subarachnoid space. The procedure is performed according to the institution's standard clinical practice. The choice of the specific local anesthetic agent, dose, and technique will be at the discretion of the attending anesthesiologist, based on the participant's clinical characteristics.
Treatment groups
Trial outcomes
Primary outcomes
Number of Postoperative Analgesic Rescue Doses
The cumulative number of on-demand analgesic doses (2 mg morphine bolus) requested by the participant via an intravenous Patient-Controlled Analgesia (PCA) pump. The total number of requests will be recorded from the pump's memory at 48 hours postoperatively. This is the primary measure for assessing postoperative pain control.
Secondary outcomes
Immediate Postoperative Limb Mobility
Assessment of motor function in the operated limb. A binary (Yes/No) assessment will be made of the participant's ability to actively move their hip, knee, and foot.
Incidence of Postoperative Nausea and Vomiting (PONV)
The occurrence of any episode of nausea or vomiting as reported by the participant or observed by clinical staff will be recorded.
Postoperative Pain Intensity
Participant's self-reported pain intensity will be measured using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Length of Hospital Stay
The total number of days from the day of surgery to the day of discharge from the hospital, which is an indirect measure of recovery.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.