A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group and Lateral Femoral Nerve Block Following Total Hip Arthroplasty

May 2, 2025 updated by: riham fathy galal, Ain Shams University

A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group (PENG) and Lateral Femoral Nerve Block Following Total Hip Arthroplasty

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.

Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks.

Group B: Patients will receive Erector spinae plane block.

After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.

For (Group A) PENG block will be done before spinal anesthesia.

LFCN block will be performed.

For (Group B), ESP block will be done before spinal anesthesia.

Spinal anesthesia will be chosen as the main anesthetic technique.

In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.

Group A: patients will receive PENG and LFCN blocks.

Group B: Patients will receive ESP block, which will be the control group.

After obtaining approval from Ain Shams hospital academic and ethical committee, written, informed and valid consent will be taken from all participants after proper explanation of the study procedure and the expected outcome in a clear language for patients of either sex, aging from 18 to 65 years old, ASA physical status (I, II) scheduled for total hip arthroplasty surgeries.

Patients with the following criteria will be excluded from the study: Patient refusal, ASA physical status III or more, known allergy to any of the study drugs, infection at the site of injection, history of cardiovascular, renal, hepatic or neuromuscular diseases, history of any psychiatric disorder, presence of any coagulopathy, chronic opioid, gabapentin or pregabalin use, BMI more than 35 kg/m2. Patients will be randomly assigned to either both PENG and LFCN blocks and ESP block with ultrasound guidance before spinal anesthesia.

After IV access insertion and oxygen nasal cannula application, ECG (Electrocardiography), pulse oximeter, noninvasive blood pressure monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.

For (Group A) PENG block will be done before spinal anesthesia ultrasound-guided using a curvilinear array ultrasound transducer (2-5 MHz) Sono site M-turbo ultrasonography. While the patient is in the supine position, the probe will be placed in parallel to the inguinal crease and will be rotated clockwise until visualizing femoral artery, iliopsoas muscle tendon, anterior inferior iliac spine (AIIS) and ilio-pubic eminence. 22G 80 mm needle will be inserted in plane from lateral side of probe until tip of needle touch iliopubic eminence, after negative aspiration 20 ml of bupivacaine 0.5% will be injected. Success of injection will be confirmed by fluid spreading between the iliopsoas tendon and periosteum of iliopubic eminence.

LFCN block will be performed using linear ultrasound probe (10-15 MHz). while the patient is in supine position the probe will be directed caudally to AIIS until visualizing LFCN between sartorius muscle and tensor fascia latae. 5 ml of bupivacaine will be injected after negative aspiration.

For (Group B), ESP block will be done before spinal anesthesia in the lateral decubitus position by curvilinear probe (2-5 MHz). Probe will be placed on the third lumber vertebra in the parasagittal line to identify the transverse process of L3. Needle will be directed in plane caudo-cephalic to the lateral edge of L3 transverse process. 30 ml of bupivacaine will be injected under visualization along the erector spinae plane. Correct placement will be defined by spread of local anesthetic cranially and caudally from injection point, dissecting the plane between the transverse processes and erector spinae muscles.

Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at L2-L3 or L3-L4 space with 25 ug of fentanyl as adjuvant while patient is in setting position.

In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients American Society of anesthesiologists' physical status (ASA) I to III.
  2. Aged 18 to 65 years.
  3. Both sexes.
  4. Patients scheduled for total hip arthroplasty.

Exclusion Criteria:

  1. Patient refusal
  2. ASA physical status III or more.
  3. Patients with known allergy to any of the study drugs.
  4. Infection at the site of injection.
  5. Patients with history of cardiovascular disease.
  6. Patients with renal disease.
  7. Patients with hepatic disease.
  8. Patients with neuromuscular disease.
  9. Presence of any coagulopathy.
  10. Chronic opioid, gabapentin or pregabalin use.
  11. Patients with history of any psychiatric disorder.
  12. BMI more than 35 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined hip joint PENG block and LFCN block
Combined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block
Procedure: PENG block
pericapsular nerve group block
Procedure: LFCN block
Lateral femoral cutaneous nerve block
Experimental: ESP block
Erector spinae plane block(ESP)
Procedure: ESP block
Erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Time Frame: 48 hours
The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
48 hours
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
Time Frame: 48 hours
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
48 hours
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
Time Frame: 48 hours
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAMSU R79/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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