An interventional study of Pericapsular Nerve Group Blocks with Local Infiltration Analgesia and spinal anesthesia in Hip Fractures, Arthroplasty, Replacement, Hip and Pain, Postoperative, sponsored by ASST Gaetano Pini-CTO. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by ASST Gaetano Pini-CTO · Not applicable, Interventional, and Treatment
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:
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.
Study Rationale Standard anesthetic techniques for hip fracture surgery in the target population, which often includes fragile and elderly individuals, present distinct challenges. Both neuraxial (spinal) and general anesthesia can have a significant hemodynamic impact. Furthermore, traditional regional anesthetic techniques like lumbar plexus or femoral nerve blocks, while providing effective analgesia, often result in significant motor and sensory blockade of the lower limb, which can impede early mobilization and rehabilitation.
This study investigates a motor-sparing anesthetic approach. The intervention is based on pericapsular nerve group blocks (A-PENG and PONG), anterior and posterior, which target only the sensory articular branches innervating the hip capsule. This technique, combined with local infiltration analgesia (LIA), aims to provide comprehensive surgical anesthesia and post-operative analgesia without affecting motor function, thereby facilitating immediate post-operative mobilization.
Anesthetic Intervention Details (PENG 360° Arm) Participants randomized to the investigational arm will receive a combination of three injections prior to surgical incision. A convex ultrasound probe will be used for A-PENG and PONG.
During surgery, participants in this arm will receive supplemental oxygen and sedation with propofol, with the depth of anesthesia monitored using a Bispectral Index (BIS) monitor.
Post-operative Pain Management Protocol To ensure a standardized approach to analgesia for all participants in both study arms, a uniform post-operative pain management protocol will be implemented. Unless contraindicated, all participants will receive a fixed-dose regimen of intravenous paracetamol (1000 mg) and ketorolac (30 mg) every 8 hours.
In addition, all participants will be provided with an intravenous patient-controlled analgesia (PCA) pump delivering morphine. The PCA pump will be set to deliver on-demand rescue boluses of 2 mg of morphine with no continuous background infusion. The maximum daily dose will be limited to 10 mg for participants over 65 years of age and 20 mg for those 65 or younger.
Data Management and Randomization Participant data will be collected and managed using an electronic Case Report Form (CRF) built with Google Forms and stored in a secure cloud database (Google Sheets). All data will be pseudonymized using a unique alphanumeric identifier assigned at the time of enrollment to ensure participant confidentiality.
Randomization will be performed using a dedicated Google Form configured to provide response options in a random order. The investigator will select the first option presented to assign the participant to either the "case" or "control" group19.
Statistical Analysis Plan Descriptive statistics (mean, median, standard deviation, min/max) will be used to summarize the collected data. The primary endpoint (cumulative number of PCA rescue doses at 48 hours) will be analyzed using a Poisson distribution model.
For other outcomes, a Chi-square test will be used for categorical variables (e.g., need for conversion to general anesthesia), while a t-test (or a non-parametric equivalent) will be used for continuous variables (e.g., NRS pain scores in the recovery room). Analysis of covariance and multiple linear regression may also be conducted to evaluate the role of demographic and clinical characteristics on study outcomes.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's planned enrollment of 100 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →ASST Gaetano Pini-CTO is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive a motor-sparing anesthetic technique. This consists of three ultrasound-guided injections performed before surgery: an anterior Pericapsular Nerve Group (PENG) block, a Local Infiltration Analgesia (LIA) of the incision line, and a posterior PENG (PONG) block.
Procedure: Pericapsular Nerve Group Blocks with Local Infiltration Analgesia
Participants assigned to this arm will receive standard spinal anesthesia. The procedure will be performed according to the center's standard practice and guidelines, with the choice of local anesthetic and dosage at the discretion of the anesthesiologist
Procedure: spinal anesthesia
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.
Also known as: PENG 360°; A-PENG +PONG +LIA
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.
Also known as: Spinal Block; Subarachnoid Block
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.
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.
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.
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.
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.
Plan to share: Yes — Plan Description Individual Participant Data (IPD) that will be shared: The full, de-identified participant dataset. The final study protocol. The statistical analysis plan. How to access the data: Data will be available to qualified researchers for non-commercial, academic purposes upon reasonable request. Interested researchers should submit a formal proposal outlining their research goals to the Principal Investigator. Data sharing timeline: Data will be made available after the publication of the primary study results and will remain available for a period of 5 years.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be made available starting 6 months after the publication of the primary manuscript. Data will remain available for a period of 5 years following publication.
Access criteria: Access to the de-identified individual participant data and supporting documents will be granted to qualified academic researchers for non-commercial purposes, such as secondary analysis or meta-analysis. Researchers must submit a formal research proposal to the Principal Investigator for review. A signed data sharing agreement will be required before data is transferred.
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