- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06679764
The Ultrasound Guided Pericapsular Nerve Group and Anterior Quadratus Lumborum Blocks in Hip Replacement Surgeries
Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Anterior Quadratus Lumborum Block in Elderly Patients Undergoing Total Hip Replacement Surgeries: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Aim of the work:
The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block
Statistical Analysis:
Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of Medicine, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders
- Type of surgery; unilateral elective total hip replacement.
- Physical status ASA I- III
- Age ≥ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
- Traumatic fracture hip through anterolateral approach.
Exclusion Criteria:
- Patient refusal.
- Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics & opioids).
- History of psychological disorders and/or chronic pain.
- Pre- existing peripheral neuropathies
- Coagulopathy.
- Infection of the skin at the site of needle puncture area.
- Active cardiac condition (unstable coronary syndromes, significant arrhythmias, severe valvular disease).
- Acute respiratory disease (active chest infection, respiratory failure).
- Advanced liver disease (increased liver enzymes >3 folds) or severe kidney disease (creatinine >2).
- long operative time more than 3 hours.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Anterior quadratus lumborum block technique (AQLB)
AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process. A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane. |
AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process. A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane. |
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Active Comparator: Pericapsular Nerve Group (PENG) block
With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus.
In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed.
With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly.
Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline.
Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread.
|
With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus.
In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed.
With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly.
Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline.
Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread.
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Active Comparator: Control Group
Pataints received opioid analgesia with GA
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Pataints received opioid analgesia with genaral anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Total Amount of Morphine Consumption
Time Frame: Immediatly post operative for 24 hours
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Total dose of IV morphine (mg) administered as rescue analgesia during the first 24 postoperative hours.
Morphine 0.05 mg/kg IV boluses were given when NRS ≥4, up to a maximum of 0.3 mg/kg/24 h.
Reported as median (IQR).
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Immediatly post operative for 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale at Rest Over First 24 Hours
Time Frame: 30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery
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Pain intensity at rest using 0-10 Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain) measured at specified time points; data reported as median (IQR).
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30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery
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Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours
Time Frame: at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Pain intensity during passive 90° hip flexion using 0-10 NRS at same time points; reported as median (IQR).
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at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Time to First Rescue Morphine Analgesia
Time Frame: Immediatly post operative for 24 hours
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Time from arrival in PACU to first administration of IV morphine rescue dose (NRS ≥4).
Reported as median (IQR).
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Immediatly post operative for 24 hours
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Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours
Time Frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Manual muscle test (0-5 scale; 0 = no contraction, 5 = full ROM against gravity and maximal resistance) for quadriceps and iliopsoas muscles on the operated side, after extubation, at predefined time points.
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30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours
Time Frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Active hip flexion range of motion (degrees) of the operated hip, from 0° to 90°, assessed at same time points as MMTe.
Reported as median (IQR).
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30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
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Total Intraoperative Fentanyl Dose
Time Frame: During surgery
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Total dose of IV fentanyl administered intraoperatively.
Additional boluses of 1 μg/kg were given if MAP or HR increased by >20% above baseline.
Reported as mean ± SD.
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During surgery
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Time to First Walk
Time Frame: From end of surgery until first walk (within postoperative 24 h)
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Time from end of surgery to first ambulation (≥3 steps with walker).
Reported as median (IQR)
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From end of surgery until first walk (within postoperative 24 h)
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Length of Hospital Stay
Time Frame: From date of surgery until discharge
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Time from surgery to hospital discharge.
Reported as mean ± SD.
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From date of surgery until discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A Ollaek, MD, Cairo 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-16-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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