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

NCT06679764 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MD-16-2022
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Analgesia

Outcome Measures

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).

  Immediatly post operative for 24 hours

Secondary Outcomes (8)

• Numeric Pain Rating Scale at Rest Over First 24 Hours

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

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

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

• Time to First Rescue Morphine Analgesia

  Immediatly post operative for 24 hours

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

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

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

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

Study Arms (3)

Anterior quadratus lumborum block technique (AQLB)

ACTIVE COMPARATOR

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)

Pericapsular Nerve Group (PENG) block

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

Pataints received opioid analgesia with GA

Drug: Control Group

Interventions

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.

Anterior quadratus lumborum block technique (AQLB)

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.

Pericapsular Nerve Group (PENG) block

Control Group DRUG

Pataints received opioid analgesia with genaral anesthesia

Control Group

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Dental Occlusion; Control Groups

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Single-center study at a tertiary university hospital, which may limit generalizability. Pain and motor assessments are partly subjective. Follow-up was restricted to the first 24 postoperative hours; long-term functional outcomes and block-related complications beyond this period were not assessed.

Results Point of Contact

• Title: Dr. Alaa F. Abd Elbadei - Corresponding Author
• Organization: Department of Anesthesia, Surgical Intensive Care, and Pain Management, Faculty of Medicine, Cairo University, Cairo, Egypt.

alaa.fouad@gmx.com

01222224057

Study Officials

• Mohamed A Ollaek, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: May 1, 2022
• Primary Completion: September 15, 2023
• Study Completion: January 31, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2025-12

Locations

EG (1)