Clinical trial NCT06679764: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 93
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: The total amount of morphine consumption
timeFrame: Immediatly post operative for 24 hours
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
measure: Heart rate
timeFrame: 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
measure: Mean Arterial Blood Pressure
timeFrame: 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
measure: Time for first rescue analgesia.
timeFrame: Immediatly post operative for 24 hours
measure: Failure rate of both blocks
timeFrame: during the first hour postoperatively
measure: Manual muscle test (MMT) for the quadriceps and Iliopsoas
timeFrame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
measure: Range of motion, where active hip flexion (between 0° and 90°)
timeFrame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed A Ollaek, MD
role: PRINCIPAL_INVESTIGATOR
References: