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

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• 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.

  Procedure: Anterior quadratus lumborum block technique (AQLB)

• 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.

  Procedure: Pericapsular Nerve Group (PENG) block

• Active comparator
  Control Group

  Pataints received opioid analgesia with GA

  Drug: Control Group

Interventions

• ProcedureAnterior 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.

• ProcedurePericapsular 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.

• DrugControl Group

  Pataints received opioid analgesia with genaral anesthesia

Primary outcomes

1. The Total Amount of Morphine Consumption

   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).

   Time frame: Immediatly post operative for 24 hours

Secondary outcomes

1. Numeric Pain Rating Scale at Rest Over First 24 Hours

   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).

   Time frame: 30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery

2. Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours

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

   Time frame: at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively

3. Time to First Rescue Morphine Analgesia

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

   Time frame: Immediatly post operative for 24 hours

4. Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours

   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.

   Time frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively

5. Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours

   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).

   Time frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively

6. Total Intraoperative Fentanyl Dose

   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.

   Time frame: During surgery

7. Time to First Walk

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

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

8. Length of Hospital Stay

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

   Time frame: From date of surgery until discharge

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 16, 2022

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