- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003738
Postoperative Analgesia After Total Hip Arthroplasty: Comparative Evaluation of Pericapsular Nerve Group Versus Fascia Iliaca Compartment Block
Postoperative Analgesia After Total Hip Arthroplasty: Comparative Evaluation of Pericapsular Nerve Group Versus Fascia Iliaca Compartment Block in a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.
Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.
The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after total hip arthroplasty (THA) while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.
Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.
Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11588
- Ain shams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 80 years.
- Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status II-III.
- Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.
Exclusion Criteria:
- Patients' refusal
- Contraindications to spinal anesthesia or nerve blocks.
- History of allergy to the medications used in the study.
- Pregnancy.
- Significant cognitive impairment.
Study Plan
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 |
|---|---|
|
Experimental: Group A
Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block.
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Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block.
|
|
Active Comparator: Group B
Patients received an ultrasound-guided pericapsular nerve group (PENG) block.
|
Patients received an ultrasound-guided pericapsular nerve group (PENG) block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Degree of pain was assessed using the Visual Analogue Scale (VAS).
VAS is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain.
VAS was recorded at 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
|
24 hours postoperatively
|
|
Total amount of nalbuphine consumption
Time Frame: 24 hours postoperatively
|
If the postoperative Visual Analogue Scale (VAS) was greater than 3, an intravenous dose of 5 mg Nalbuphine diluted in 5 mL of saline was administered as needed.
|
24 hours postoperatively
|
|
Number of cases needing rescue doses
Time Frame: 24 hours postoperatively
|
The number of cases needing rescue doses was recorded.
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24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative ambulation
Time Frame: 24 hours postoperatively
|
Time from completion of surgery to first assisted standing and walking ≥2 meters was recorded as the ambulation time.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Diaaeldin DA Aboelnile, MD, Lecturer, Faculty of medicine, Ain Shams university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- FMASU MD76/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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