AzTrials
AzTrials

Post Operative PainNCT06402006

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

A study testing PENG block, LFCN block and ESP block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post Operative Pain
What is being tested?
PENG block, LFCN block and ESP block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
15 May 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patient refusal
  • ASA physical status III or more.
  • Patients with known allergy to any of the study drugs.
  • Infection at the site of injection.
  • Patients with history of cardiovascular disease.
  • Patients with renal disease.
Show all 12Show fewer
  • Patients with hepatic disease.
  • Patients with neuromuscular disease.
  • Presence of any coagulopathy.
  • Chronic opioid, gabapentin or pregabalin use.
  • Patients with history of any psychiatric disorder.
  • BMI more than 35 kg/m2.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university hospitals

    Cairo

Other trials in Egypt

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
PENG block, LFCN block, ESP block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PENG blockProcedure or surgery

    pericapsular nerve group block

  • LFCN blockProcedure or surgery

    Lateral femoral cutaneous nerve block

  • ESP blockProcedure or surgery

    Erector spinae plane block

Study groups in NCT06402006
Study groupRoleWhat they receive
Combined hip joint PENG block and LFCN blockExperimentalCombined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block
Receives: Procedure: PENG block; Procedure: LFCN block
ESP blockExperimentalErector spinae plane block(ESP)
Receives: Procedure: ESP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

    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).

    Measured: 48 hours

  2. presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.

    presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.

    Measured: 48 hours

  3. analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).

    analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start15 May 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402006
Sponsor's protocol ID
FAMSU R79/2024
Status last verified
May 2025
First submitted
28 Apr 2024
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PENG block, LFCN block and ESP block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in