PENG Block With or Without PPD Block for Postoperative Analgesia After Total Hip Arthroplasty
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Guzin Ceran, MD, Kirsehir Ahi Evran University Faculty of Medicine, Kirsehir Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KAEAH-THA-PENG-PPD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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