- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531030
Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blocks for Hip Surgery Analgesia
Efficacy of Combining Ultrasound-guided Posterior Pericapsular Deep Gluteal Block to Both Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blocks for Postoperative Analgesia in Orthopedic Hip Surgeries
Study Overview
Status
Conditions
Detailed Description
Patients undergoing elective orthopedic hip surgery will be randomly assigned to one of two groups. Both groups will receive general anesthesia followed by ultrasound-guided nerve blocks. Group 1 will receive a Pericapsular Nerve Group block and a Lateral Femoral Cutaneous Nerve block using 0.25% bupivacaine. Group 2 will receive these same two blocks plus an additional Posterior Pericapsular Deep gluteal block, also using 0.25% bupivacaine.
The primary goal is to evaluate postoperative pain using the Numerical Rating Scale at 6, 12, and 24 hours for both static and dynamic states. Secondary objectives include assessing quadriceps muscle strength using the Lovett Grading Method, measuring total rescue analgesia (nalbuphine) consumption, and monitoring for any complications or differences in length of hospital stay.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merna H Hilal, MSc, MB Bch
- Phone Number: +201142220555
- Email: Merna.hazem@med.asu.edu.eg
Study Contact Backup
- Name: Hany M El Zahaby, MD
- Phone Number: +201227463000
- Email: Hanyzahaby@hotmail.com
Study Locations
-
-
Abbasia
-
Cairo, Abbasia, Egypt, 11591
- Ain Shams University
-
Contact:
- 01210366210
-
Contact:
- Merna H Hilal, MB BCh, MSc
- Phone Number: +201142220555
- Email: merna.hazem@med.asu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Both genders included.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Undergoing elective orthopedic hip surgery.
- Provision of written informed consent.
Exclusion Criteria:
- Patient refusal of procedure or participation.
- American Society of Anesthesiologists (ASA) physical status classification IV.
- Allergy to any of the drugs used in the study.
- Local skin infection at the injection site.
- Coagulation disorder.
- History of cardiac arrhythmia, seizures, or increased intracranial tension.
- Alcohol or drug abuse, or psychiatric disease.
- History of chronic pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blocks.
Patients receive ultrasound-guided Pericapsular Nerve Group block and Lateral Femoral Cutaneous Nerve block using 10-15 ml of 0.25% bupivacaine for each block.
|
Patients receive ultrasound-guided Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve blocks with 10-15 ml of 0.25% bupivacaine for each block.
|
|
Experimental: Posterior Pericapsular Deep Gluteal, Pericapsular Nerve Group, Lateral Femoral Cutaneous Nerve Block
Patients receive ultrasound-guided Pericapsular Nerve Group block, Lateral Femoral Cutaneous Nerve block, and Posterior Pericapsular Deep gluteal block using 10-15 ml of 0.25% bupivacaine for each block.
|
Under ultrasound guidance, patients receive a Pericapsular Nerve Group block, a Lateral Femoral Cutaneous Nerve block, and a Posterior Pericapsular Deep gluteal block.
For each of the three blocks, 10-15 ml of 0.25% bupivacaine is injected while observing for adequate fluid spread over the respective anatomical targets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Postoperative analgesic effect through Numerical Rating Scale Pain Score.
Time Frame: 6, 12, and 24 hours postoperatively.
|
Evaluation of postoperative analgesic effect through the Numerical Rating Scale for both static and dynamic pain.
Static pain is measured after the patient has rested in bed for 15 minutes.
Dynamic pain is measured with the hip joint flexed to 45 degrees.
The scale ranges from 0 (no pain) to 10 (worst possible pain).
|
6, 12, and 24 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps Femoris Muscle Strength.
Time Frame: 1 hour before patient movement.
|
Evaluation using the Lovett Grading Method, a manual muscle testing scale from 0 (no contractility) to 5 (complete range of motion against full resistance).
|
1 hour before patient movement.
|
|
Total Rescue Analgesia Consumption.
Time Frame: First 24 hours postoperatively.
|
Total doses of intravenous nalbuphine (in milligrams) administered to the patient.
|
First 24 hours postoperatively.
|
|
Length of Hospital Stay.
Time Frame: Approximately 24-72 hours (up to hospital discharge).
|
The total number of days from the date of surgery until hospital discharge.
|
Approximately 24-72 hours (up to hospital discharge).
|
|
Occurrence of Postoperative Complications.
Time Frame: First 24 hours postoperatively.
|
Monitoring for nausea, vomiting, dizziness, or infection/hematoma at the puncture site.
|
First 24 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Wounds and Injuries
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Leg Injuries
- Fractures, Bone
- Osteoarthritis
- Femoral Fractures
- Hip Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Hip Fractures
- Osteoarthritis, Hip
Other Study ID Numbers
- FMASU MD274/2025
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
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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