Poznan University of Medical Sciences
Poznan, 62-701, Poland
Location status: Recruiting
NCT Number: NCT07327892
Pain after hip surgery is common in older adults and may limit early mobilization, increase the need for opioid medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Effective postoperative pain management that preserves muscle strength and supports early rehabilitation is especially important in this population.
Several analgesic strategies are currently used after hip surgery. Periarticular injection (PAI), administered by the surgeon during the procedure, is commonly used as part of standard care. The pericapsular nerve group (PENG) block is a newer ultrasound-guided regional anesthesia technique that targets the sensory nerves of the hip joint while sparing motor function. It may provide effective pain relief and facilitate early mobilization. However, it is unclear whether PENG block alone is superior to periarticular injection, and whether combining both techniques provides additional benefit.
The aim of this randomized controlled clinical study is to compare three postoperative analgesic strategies in older adults undergoing hip surgery: PENG block alone, PENG block combined with periarticular injection, and periarticular injection alone. Participants will be randomly assigned to one of three study groups.
The primary hypothesis is that regional anesthesia with a PENG block, either alone or combined with periarticular injection, will provide superior postoperative pain control compared with periarticular injection alone. A secondary hypothesis is that the combination of PENG block and periarticular injection will offer additional analgesic benefit compared with PENG block alone.
Outcomes assessed in this study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of adverse events relevant to older adults, such as hypotension, excessive sedation, or postoperative delirium.
The results of this study may help determine the most effective and practical analgesic strategy for hip surgery in older adults and support evidence-based optimization of postoperative pain management.
Interested in participating?
Request Info65 year–100 year
All sexes
Interventional
Not applicable
Poznan, 62-701, Poland
Location status: Recruiting
Postoperative pain following hip surgery is a major clinical challenge in older adults and is associated with delayed mobilization, increased opioid consumption, higher risk of delirium, and prolonged hospitalization. Analgesic strategies that provide effective pain relief while preserving motor function are particularly important to support early rehabilitation and reduce postoperative complications in this vulnerable population.
Periarticular injection (PAI), administered intraoperatively by the surgeon, is widely used as part of multimodal analgesia after hip surgery and is considered standard practice in many institutions. The pericapsular nerve group (PENG) block is a relatively new ultrasound-guided regional anesthesia technique designed to selectively block the sensory innervation of the anterior hip capsule while sparing motor nerves. Early clinical data suggest that the PENG block may improve postoperative analgesia and facilitate early mobilization; however, its comparative effectiveness relative to periarticular injection, as well as the potential benefit of combining both techniques, remains insufficiently studied.
This study is designed as a prospective, randomized, controlled, three-arm clinical trial comparing different postoperative analgesic strategies in older adults undergoing hip surgery. Eligible participants will be randomly assigned to one of three groups:
The primary objective of the study is to compare the effectiveness of these three analgesic strategies in controlling postoperative pain after hip surgery in older adults. Secondary objectives include assessment of opioid consumption, time to first mobilization, functional recovery, and patient comfort. Safety outcomes will also be evaluated, with particular attention to adverse events relevant to older adults, including hypotension, bradycardia, excessive sedation, nausea, vomiting, and postoperative delirium.
The results of this study are expected to provide clinically meaningful evidence on whether the PENG block offers advantages over standard periarticular injection and whether combining both techniques yields additional benefit. These findings may inform clinical decision-making and contribute to the optimization of postoperative pain management strategies for older adults undergoing hip surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided regional anesthesia technique targeting sensory innervation of the anterior hip capsule, performed as a single injection prior to surgery using a standardized protocol.
Other names: Ultrasound-guided PENG block
Intraoperative periarticular injection performed by the surgeon according to a standardized institutional protocol as part of postoperative pain management.
Other names: Local infiltration analgesia; periarticular local anesthetic injection
Time frame: 0-48 hours after surgery
Cumulative dose of all opioid analgesics administered in the postoperative period, converted to oral morphine milligram equivalents (MME). Values at 24 and 48 hours will be recorded and compared between groups.
Time frame: Within 48 hours after the end of surgery
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
Time frame: 4 hours after surgery
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame: 8 hours after surgery
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame: 12 hours after surgery
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame: 24 hours after surgery
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame: 48 hours after surgery
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame: 4 hours after surgery
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Time frame: 8 hours after surgery
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Time frame: 12 hours after surgery
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Time frame: 24 hours after surgery
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Time frame: 48 hours after surgery
Pain intensity during standardised hip movement (e.g., flexion or assisted mobilization) assessed using the 0-10 Numerical Rating Scale. Mean NRS scores at each time point will be compared between groups.
Time frame: 0-48 hours after surgery
Presence of nausea and/or vomiting requiring antiemetic therapy. The proportion of patients with at least one episode of PONV will be recorded and compared between groups
Time frame: From block placement until hospital discharge, up to 30 days
Incidence of complications potentially related to the PENG block or perineural adjuvants, including signs of local anesthetic systemic toxicity, prolonged motor or sensory deficit, nerve injury (evaluated in the postoperative clinic or outpatient nerve injury clinic if required), infection at the injection site, hematoma, or persistent weakness.
Time frame: 4 hours after surgery
Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia
Time frame: 8 hours after surgery
Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia
Time frame: 12 hours after surgery
Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia
Time frame: 24 hours after surgery
Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia
Time frame: 48 hours after surgery
Quadriceps muscle strength will be evaluated using the Medical Research Council (MRC) scale, ranging from 0 (no contraction) to 5 (normal power), at 4, 8, 12, 24, and 48 hours to detect any motor impairment associated with the applied regional anesthesia
Contact information is provided by the study sponsor or research team.
Poznan University of Medical Sciences
Other
Comparison of Pericapsular Nerve Group (PENG) Block, PENG Block Plus Periarticular Injection, and Periarticular Injection Alone for Postoperative Pain Management in Older Adults Undergoing Hip Surgery: A Randomized Controlled Trial
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