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
Phase 4
Completed
- Conditions
- Post Operative Analgesia
- Interventions
- Procedure: Anterior quadratus lumborum block technique (AQLB)Procedure: Pericapsular Nerve Group (PENG) blockDrug: Control Group
- Registration Number
- NCT06679764
- Lead Sponsor
- Cairo University
- Brief Summary
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anterior quadratus lumborum block technique (AQLB) 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. Pericapsular Nerve Group (PENG) block 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. Control Group Control Group Pataints received opioid analgesia with GA
- Primary Outcome Measures
Name Time Method The total amount of morphine consumption Immediatly post operative for 24 hours
- Secondary Outcome Measures
Name Time Method Numeric Pain Rating Scale at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively at rest and during movement (during passive 90° hip flexion)
Heart rate baseline preoperative reading, after application of block, and every 5 minutes to give mean for each 15 minutes intervals intraoperatively then 2, 4, 6, 8, 12, 18 and 24 hours postoperatively Mean Arterial Blood Pressure baseline preoperative reading, after application of block, and every 5 minutes to give mean for each 15 minutes intervals intraoperatively then 2, 4, 6, 8, 12, 18 and 24 hours postoperatively Time for first rescue analgesia. Immediatly post operative for 24 hours Failure rate of both blocks during the first hour postoperatively block was considered failed if the patient requires more than one dose of rescue analgesia
Manual muscle test (MMT) for the quadriceps and Iliopsoas 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively Range of motion, where active hip flexion (between 0° and 90°) 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Trial Locations
- Locations (1)
Faculty of Medicine, Cairo University
🇪🇬Cairo, Egypt