- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502248
PENG Block With or Without PPD Block for Postoperative Analgesia After Total Hip Arthroplasty
March 25, 2026 updated by: Guzin Ceran, Kirsehir Ahi Evran Universitesi
Comparison of the Efficacy of Pericapsular Nerve Group (PENG) Block Versus PENG Block Added to Posterior Pericapsular Deep Gluteal (PPD) Block for Postoperative Analgesia in Total Hip Arthroplasty
This single-center, prospective, randomized controlled clinical trial aims to compare the postoperative analgesic efficacy of PENG block with or without posterior pericapsular deep gluteal block in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia.
Total hip arthroplasty is commonly associated with moderate to severe postoperative pain.
Although PENG block provides analgesia for the anterior hip capsule, some patients may still experience pain originating from the posterior capsule.
The addition of PPD block may improve analgesia by targeting posterior articular branches.
Participants will be randomized into two groups: one group will receive PENG block, and the other group will receive PENG plus PPD block.
Postoperative pain will be assessed using the Numeric Rating Scale (NRS).
The study will compare postoperative pain scores and other analgesia-related outcomes between groups.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is planned as a single-center, prospective, randomized, controlled, double-blind trial in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia.
Eligible participants will be patients aged 18 years or older, classified as ASA physical status I-III, and able to provide informed consent.
Patients with ASA IV-V, serious cardiac, respiratory, hepatic, or renal disease, neuropsychiatric disorders, cognitive impairment preventing reliable NRS assessment, coagulopathy, local anesthetic allergy, infection or scar at the block site, failed block, signs of local anesthetic systemic toxicity, exposure to local anesthetic doses above protocol limits, revision total hip arthroplasty, fracture-related total hip arthroplasty, or refusal to participate will be excluded.
Participants will be randomized by sealed-envelope method into two groups.
Group 1 will receive PENG block after spinal anesthesia in the supine position using ultrasound guidance and 20 mL of 0.25% bupivacaine.
Group 2 will receive PENG block followed by ultrasound-guided PPD block, with 30 mL of 0.25% bupivacaine used for the PPD block.
In addition, both groups will receive lateral femoral cutaneous nerve block with 5 mL of 0.25% bupivacaine.
The primary objective is to compare postoperative pain intensity between groups using Numeric Rating Scale scores.
Secondary evaluations include postoperative analgesic consumption, time to first rescue analgesia, time to first mobilization, and motor function including ankle dorsiflexion strength.
An initial pilot phase including 40 patients is planned, and the final sample size will be calculated using G*Power based on pilot data with alpha 0.05 and power 0.80.
The study will continue until the target sample size is reached.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guzin Ceran Assistant Professor, MD
- Phone Number: +90-506-163-0936
- Email: gzncrn@hotmail.com
Study Contact Backup
- Name: Abdulkadir Apaydin, MD
- Phone Number: +90-531-951-2333
- Email: apydnkadir@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18 years and older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty under spinal anesthesia
- Able to provide written informed consent
Exclusion Criteria:
- ASA physical status IV or V
- Serious concomitant cardiac, respiratory, hepatic, or renal disease
- Known neuropsychiatric disorder
- Cognitive impairment preventing understanding or response to the Numeric Rating Scale (NRS)
- Coagulopathy
- Local anesthetic allergy
- Infection or scar at the block site
- Failed block
- Refusal to participate
- Signs of local anesthetic systemic toxicity after block
- Patients in the PENG plus PPD group who would be exposed to a total local anesthetic dose above 3 mg/kg in patients weighing less than 50 kg
- Revision total hip arthroplasty
- Total hip arthroplasty planned for fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PENG Block
Participants in this arm will receive ultrasound-guided PENG block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty.
In addition, lateral femoral cutaneous nerve block will be performed.
|
Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty.
In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus.
In both groups, lateral femoral cutaneous nerve block will also be performed as part of the analgesic protocol.
Other Names:
|
|
Active Comparator: PENG Plus PPD Block
Participants in this arm will receive ultrasound-guided PENG block followed by ultrasound-guided posterior pericapsular deep gluteal block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty.
In addition, lateral femoral cutaneous nerve block will be performed.
|
Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty.
In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus.
In both groups, lateral femoral cutaneous nerve block will also be performed as part of the analgesic protocol.
Other Names:
Ultrasound-guided posterior pericapsular deep gluteal block performed after PENG block and spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty.
In Group 2, the block will be performed in the lateral decubitus position with the hip and knee flexed to 90 degrees, and 30 mL of 0.25% bupivacaine will be injected after needle placement to the posterior acetabular rim near the ischiofemoral ligament using an in-plane technique.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity at 6 hours measured by Numeric Rating Scale (NRS)
Time Frame: 6 hours after surgery
|
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
The primary comparison between groups will be the NRS score at postoperative 6 hours
|
6 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity over the first 24 hours measured by Numeric Rating Scale (NRS)
Time Frame: Recovery room, 2 hours, 12 hours, and 24 hours after surgery
|
Postoperative pain intensity will also be assessed in the recovery room and at postoperative 2, 12, and 24 hours using the Numeric Rating Scale (NRS)
|
Recovery room, 2 hours, 12 hours, and 24 hours after surgery
|
|
Total analgesic consumption during the first 24 hours
Time Frame: 24 hours after surgery
|
Total amount of analgesic medication consumed within the first 24 hours after surgery will be recorded and compared between groups
|
24 hours after surgery
|
|
Time to first rescue analgesic requirement
Time Frame: Up to 24 hours after surgery
|
Time from block performance to first additional analgesic requirement will be recorded
|
Up to 24 hours after surgery
|
|
Time to first mobilization
Time Frame: Up to 24 hours after surgery
|
Time to first standing or mobilization after surgery will be recorded and compared between groups
|
Up to 24 hours after surgery
|
|
Ankle dorsiflexion motor strength
Time Frame: Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery
|
Ankle dorsiflexion motor strength will be assessed postoperatively to evaluate possible motor weakness related to block spread.
|
Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guzin Ceran, MD, Kirsehir Ahi Evran University Faculty of Medicine, Kirsehir Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 5, 2026
Primary Completion (Estimated)
April 5, 2027
Study Completion (Estimated)
June 5, 2027
Study Registration Dates
First Submitted
March 25, 2026
First Submitted That Met QC Criteria
March 25, 2026
First Posted (Actual)
March 30, 2026
Study Record Updates
Last Update Posted (Actual)
March 30, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEAH-THA-PENG-PPD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share individual participant data with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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