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Completed

NCT Number: NCT06679764

The Ultrasound Guided Pericapsular Nerve Group and Anterior Quadratus Lumborum Blocks in Hip Replacement Surgeries

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

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Key information

Conditions

Post Operative Analgesia

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anterior quadratus lumborum block technique (AQLB)

Procedure

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

Procedure

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

Drug

Pataints received opioid analgesia with genaral anesthesia

Primary outcomes

  1. The Total Amount of Morphine Consumption

    Time frame: Immediatly post operative for 24 hours

    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).

Secondary outcomes

  1. 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

    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).

  2. 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

    Pain intensity during passive 90° hip flexion using 0-10 NRS at same time points; reported as median (IQR).

  3. Time to First Rescue Morphine Analgesia

    Time frame: Immediatly post operative for 24 hours

    Time from arrival in PACU to first administration of IV morphine rescue dose (NRS ≥4). Reported as median (IQR).

  4. 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

    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.

  5. 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

    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).

  6. Total Intraoperative Fentanyl Dose

    Time frame: During surgery

    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.

  7. Time to First Walk

    Time frame: From end of surgery until first walk (within postoperative 24 h)

    Time from end of surgery to first ambulation (≥3 steps with walker). Reported as median (IQR)

  8. Length of Hospital Stay

    Time frame: From date of surgery until discharge

    Time from surgery to hospital discharge. Reported as mean ± SD.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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