PENG Block + LIA For Endoprosthesis Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorASST Gaetano Pini-CTO

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pericapsular Nerve Group Blocks with Local Infiltration Analgesia

    Procedure/Surgery

    An 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/Surgery

    Standard 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

100 Participants
are divided into 2 treatment groups
Group A: PENG 360°Experimental treatment 1 intervention
Group B: SpinalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From arrival in the Post-Anesthesia Care Unit (PACU) up to 48 hours after surgery.

Secondary outcomes

1

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.

Time frame
Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
2

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.

Time frame
Within the first 48 hours after surgery.
3

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.

Time frame
Upon arrival in the Post-Anesthesia Care Unit (PACU), approximately 0-1 hours after surgery.
4

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.

Time frame
From the date of surgery until date of hospital discharge, assessed up to 30 days.

Other outcomes

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