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

NCT07327892 | Not Yet Recruiting

• 1 other identifier: 17/2025
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis; Arthropathy of Hip

Outcome Measures

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.

  0-48 hours after surgery

Secondary Outcomes (18)

• Time to First Rescue Analgesia

  Within 48 hours after the end of surgery

• Pain Intensity at Rest (NRS 0-10)

  4 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  8 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  12 hours after surgery

• Pain Intensity at Rest (NRS 0-10)

  24 hours after surgery

Study Arms (3)

PENG Block

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block administered as a single perineural injection prior to surgery, using a standardized technique.

Procedure: Pericapsular Nerve Group (PENG) Block

PENG Block Plus Periarticular Injection (PAI)

EXPERIMENTAL

Participants will receive an ultrasound-guided PENG block (single perineural injection prior to surgery) plus a periarticular injection administered intraoperatively by the surgeon according to a standardized protocol.

Procedure: Pericapsular Nerve Group (PENG) Block; Procedure: Periarticular Injection (PAI)

Periarticular Injection (PAI) Alone

ACTIVE COMPARATOR

Participants will receive a periarticular injection administered intraoperatively by the surgeon according to a standardized protocol, without a PENG block.

Procedure: Periarticular Injection (PAI)

Interventions

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.

Also known as: Ultrasound-guided PENG block

PENG Block; PENG Block Plus Periarticular Injection (PAI)

Periarticular Injection (PAI) PROCEDURE

Intraoperative periarticular injection performed by the surgeon according to a standardized institutional protocol as part of postoperative pain management.

Also known as: Local infiltration analgesia; periarticular local anesthetic injection

PENG Block Plus Periarticular Injection (PAI); Periarticular Injection (PAI) Alone

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48 61 873 83 03; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available beginning 6 months after publication of the primary results and will remain available for 5 years following publication.
• Access Criteria: Access to the data will be granted to researchers who provide a methodologically sound research proposal. Requests must be approved by the principal investigator and the local ethics committee, if required. Data will be shared under a data use agreement and may be used only for non-commercial scientific research purposes.

Locations

PL (1)