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NCT Number: NCT07327892

PENG Block vs PENG Plus Periarticular Injection vs Periarticular Injection in Older Adults

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

About this study

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:

  • PENG block alone,
  • PENG block combined with periarticular injection, or
  • periarticular injection alone. The PENG block will be performed under ultrasound guidance by an experienced anesthesiologist prior to surgery using a standardized technique. Periarticular injection will be administered intraoperatively by the operating surgeon according to a standardized institutional protocol. Apart from the assigned analgesic strategy, all participants will receive standardized anesthesia and postoperative multimodal pain management to minimize confounding factors.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Written informed consent obtained from the patient or legal representative

Exclusion criteria

  • 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
  • Infection at or near the injection site
  • Severe hepatic or renal impairment
  • History of chronic opioid use (daily opioids >30 days before surgery)
  • Cognitive impairment or delirium precluding reliable pain assessment
  • BMI > 40 kg/m² (if you want to exclude for technical difficulty)
  • Patients receiving another regional nerve block for hip surgery
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 30 days

Treatment and study plan

pericapsular nerve group (PENG) block

Procedure

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

Periarticular Injection (PAI)

Procedure

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

Primary outcomes

  1. otal Opioid Consumption

    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.

Secondary outcomes

  1. Time to First Rescue Analgesia

    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.

  2. Pain Intensity at Rest (NRS 0-10)

    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.

  3. Pain Intensity at Rest (NRS 0-10)

    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.

  4. Pain Intensity at Rest (NRS 0-10)

    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.

  5. Pain Intensity at Rest (NRS 0-10)

    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.

  6. Pain Intensity at Rest (NRS 0-10)

    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.

  7. Pain Intensity During Movement (NRS 0-10)

    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.

  8. Pain Intensity During Movement (NRS 0-10)

    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.

  9. Pain Intensity During Movement (NRS 0-10)

    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.

  10. Pain Intensity During Movement (NRS 0-10)

    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.

  11. Pain Intensity During Movement (NRS 0-10)

    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.

  12. Incidence of Postoperative Nausea and Vomiting (PONV)

    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

  13. Block-Related Adverse Events, Including Neurological Complications

    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.

  14. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    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

  15. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    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

  16. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    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

  17. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    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

  18. Motor Function Preservation (Quadriceps Strength, MRC Scale)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Malgorzata Reysner, MD PhD

CONTACT

[email protected]

+48 61 873 83 03

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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