PENG Block vs PENG Plus Periarticular Injection vs Periarticular Injection in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 years or older
Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
ASA physical status I-III
Ability to communicate pain intensity using the NRS scale
Disqualifiers
Patient refusal or inability to provide informed consent
Allergy, intolerance, or contraindication to any study medication: ropivacaine
Pre-existing neurological deficit or neuropathy of the affected limb
Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Pericapsular Nerve Group (PENG) Block
Procedure/SurgeryUltrasound-guided regional anesthesia technique targeting sensory innervation of the anterior hip capsule, performed as a single injection prior to surgery using a standardized protocol.
Periarticular Injection (PAI)
Procedure/SurgeryIntraoperative periarticular injection performed by the surgeon according to a standardized institutional protocol as part of postoperative pain management.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: PENG BlockActive comparator 1 intervention
Group B: PENG Block Plus Periarticular Injection (PAI)Experimental treatment 2 interventions
Group C: Periarticular Injection (PAI) AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
otal Opioid Consumption
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
0-48 hours after surgerySecondary outcomes
1
Time to First Rescue Analgesia
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
Within 48 hours after the end of surgery2
Pain Intensity at Rest (NRS 0-10)
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 surgery3
Pain Intensity at Rest (NRS 0-10)
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 surgery4
Pain Intensity at Rest (NRS 0-10)
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 surgerySponsors and contacts
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Source ClinicalTrials.gov