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Acute Post Operative PainNCT06917807

Pain Relief Comparison: Pericapsular Nerve Group Versus Quadratus Lumborum Block for Positioning in Femur Fracture Surgery

A study testing Pericapsuler nerve group block and Quadratus lumborum block in people with Acute Post Operative Pain and Hip Fracture, 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
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Trial summary

This study aims to compare the analgesic efficacy of Ultrasound Guided Pericapsular Nerve Group Block and Quadratus Lumborum Block for pain relief During patient Positioning for Spinal Anesthesia in proximal femur fracture surgeries. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Pericapsuler nerve group block and Quadratus lumborum block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteEgypt
Study dates
10 Apr 2025to 10 Jan 2026
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients aging > 21 years of both sexes.
  • Patients scheduled for fixation of proximal femur fracture under spinal anesthesia.
  • ASA Physical Status Class I, II or ш.

Who cannot join

  • Patient refusal to participate.
  • Patients receiving opioids for chronic analgesic therapy.
  • in ability to comprehend the visual analog scale.
  • Coagulopathy ( INR > 1.4, platelets < 80000/mm3, or bleeding disorder).
  • Infection at the injection site.
  • Allergy to local anesthetics.
Show all 9Show fewer
  • Polytroma patients ( e.g., concurrent major thoracic/ abdominal injuries)
  • Severe cardiopulmonary disease (e.g., low fixed cardiac output, NYHA class 3/4).
  • Neurological disease (e.g., peripheral neuropathy, multiple sclerosis).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams university

    Cairo, Abassya, 00202

Other trials in Egypt

About this study

Official title: Comparative Evaluation of Analgesic Efficacy of Ultrasound Guided Pericapsular Nerve Group Block and Quadratus Lumborum Block During Positioning of Patients With Proximal Femur Fractures for Spinal Anesthesia

This study aims to compare the analgesic efficacy of Ultrasound Guided Pericapsular Nerve Group Block and Quadratus Lumborum Block for pain relief During patient Positioning for Spinal Anesthesia in proximal femur fracture surgeries. A total of 42 patients enrolled and randomly assigned to either the PENG or QLB group (n=21 each). pain relief will be assessed using the visual analog scale (VAS) at rest and during movement before and after the block, as well as the time of first rescue analgesia and total analgesic consumption. the study will also evaluate the ease of spinal positioning and anesthesiologist satisfaction. patient will be monitored intraoperatively and postoperatively for pain scores. adverse events, and analgesic requirement.

Read the detailed description

The study aim to compare between ultrasound guided pericapsular nerve group block ( PENG) and quadratus lumborum (QLB) block using VAS score to assess the overall efficacy for pain relief during patient positioning for spinal anesthesia.

After approval of anesthesiology department scientific and ethical committees in Ain Shams University Hospitals, 42 patients will be included in the study, and will be divided into two groups (n=21; each); group PENG and QLB group.

The two groups will be adequately monitored and assessed before spinal anesthesia and post-operatively and they will be compared regarding analgesic outcome by using the visual analogue scaling system, besides, recording time for first call for rescue analgesia and total amount of analgesia require.

Preoperative setting:

Complete history taking and full physical examination. Routine preoperative investigations will be done to all patients including laboratory investigations (complete blood picture, liver function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition ( e.g. kidney function, ECHO, ECG, chest X-ray Written informed consent will be obtained from all participants prior to the study.

In the preoperative room: pain score at rest (VAS-R) and at 15-degree passive limb elevation in the supine position to assess pain during movement (dynamic VAS (VAS-D)) will be recorded before giving block.

The two blocks will be performed by the most experienced anesthesiologist in the group.

In group A (PENG): the regional block will be performed with the patient in the supine position. Ultrasound machine with low frequency curvilinear probe (2-5MHz) covered with sterile sheath (Sonoscape® SSI 6000, China) will be initially placed in a transverse plane over the Anterior Inferior Iliac Spine (AIIS) and then aligned with the pubic ramus by rotating the probe counter-clockwise approximately 45 degrees. In this view, the Iliopectineal Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution (30ml of bupivacaine 0.25%) will be injected in 5-mL increments while observing for adequate fluid spread in this plane, without exceeding the toxic dose (3 mg/kg).

In group B (QLB): the block will be performed with the patient in the supine position. Under ultrasound guidance with a low frequency curvilinear probe (2-5MHz) covered with sterile sheath (Sonoscape® SSI 6000, China), the probe will be placed in coronal plane at midaxillary line between subcostal margin and iliac crest. A 22-gauge, 80-mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted distal to subcostal margin and advanced under curvilinear probe. The needle will be advanced through external oblique aponeurosis, internal oblique, and transversus abdominis muscles. Visualizing the tip penetrating the posterior epimysium of QLM and entering anterior thoracolumbar fascia (ATLF). A small volume of local anesthetic will be injected after locating the needle tip and a negative aspiration for blood. After the distribution of the local anesthetic will be seen, the rest of the 30 mL of 0.25 % of bupivacaine will be injected.

Following the block, heart rate and mean blood pressure will be recorded every 5 min to ensure the blockade is adequate and to monitor the sign of local anesthetic toxicity for 15 min.

If local anesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 1.5 ml/kg over 2-3 min will be given.

VAS will be assessed at rest (VAS-R) and 15-degree limb elevation (VAS-D) every 10 min for 30 min. After 30 min, patients will be shifted to the operative room.

The median reduction in the VAS score from baseline to 30 minutes will be recorded.

Intraoperative setting:

An intravenous ringer lactate infusion (10-20 ml/kg for 15-20 minutes ) prior to the administration of spinal anesthesia. The patient will be monitored during the procedure using pulse oximetry, non-invasive blood pressure and electrocardiogram.

Patients will be asked to sit for spinal anesthesia. At that time, comfort during sitting for spinal anesthesia will be assessed by the ease of spinal position score (EOSP) (1-sitting without pain and minimal help, 2-mild pain detected by grimacing or verbal expression, 3-severe pain but tolerates positioning with help, 4-unable to sit, requires additional analgesia) . The anesthesiologist who perform spinal anesthesia will be surveyed by team members for operator satisfaction (excellent, good, average, poor) regarding the patient's position. If the patient cannot sit due to pain and VAS was ≥ 4, it will be considered block failure. The patient will be excluded from the study, then patient will receive general anesthesia.

All patients will receive the standard technique of spinal anesthesia in the sitting position after 30 min from the performance of the block by an expert anesthesiologist who is blind and different from the anesthesiologist who perform the two blocks.

For the two groups, spinal anesthesia will be performed under complete aseptic conditions using spinal needle of 25-G, 3 ml bupivacaine 0.5% (heavy Marcaine). Intraoperative antiemetic will be routinely administered, in form of dexamethasone 8 mg IV and ondansetron 4 mg I.V unless contraindicated.

The VAS score will be measured immediately postoperatively and every 2 hours during the first 6 hours and then every 6 hours for only first 24 hours postoperative while patients still at hospital.

If the VAS score is > 4, rescue analgesia will be given; a nalbuphine 0.2 mg/kg IV ; first analgesic request time and the total dose of nalbuphine will be recorded.

Being tested
Pericapsuler nerve group block, Quadratus lumborum block
Keywords
regional anesthesia, pain managment, QLB block, PENG block, Hip fracture, postoperative analgesia, nerve block, opioid sparing anesthesia, acute pain control, clinical trial
Medical subject headings
Pain, Postoperative, Hip Fractures

What participants receive

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

  • Pericapsuler nerve group blockProcedure or surgery

    A single shot pericapsular nerve group block preformed under ultrasound guidance with a local anesthetic agent ( Marcaine )

  • Quadratus lumborum blockProcedure or surgery

    A single shot Quadratus lumborum block preformed under ultrasound guidance with a local anesthetic agent ( Marcaine )

Study groups in NCT06917807
Study groupRoleWhat they receive
Pericapsular nervegroup blockActive comparatorthe regional block will be performed with the patient in the supine position. Ultrasound machine with low frequency curvilinear probe (2-5MHz) covered with sterile sheath will be initially placed in a transverse plane over the Anterior Inferior Iliac Spine (AIIS) and then aligned with the pubic ramus by rotating the probe counter-clockwise approximately 45 degrees. In this view, the Iliopectineal Eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anaesthetic solution (30ml of bupivacaine 0.25%) will be injected in 5-mL increments while observing for adequate fluid spread in this plane, without exceeding the toxic dose (3 mg/kg)
Receives: Procedure: Pericapsuler nerve group block
Quadratus lumborum blockActive comparatorthe block will be performed with the patient in the supine position. Under ultrasound guidance with a low frequency curvilinear probe (2-5MHz) covered with sterile sheath, the prob will be placed in coronal plane at midaxillary line between subcostal margin and iliac crest. A 22-gauge, 80-mm needle will be inserted distal to subcostal margin and advanced under curvilinear probe. The needle will be advanced through external oblique aponeurosis, internal oblique, and transversus abdominis muscles. Visualizing the tip penetrating the posterior epimysium of QLM and entering anterior thoracolumbar fascia (ATLF). A small volume of local anaesthetic will be injected after locating the needle tip and a negative aspiration for blood. After the distribution of the local anesthetic will be seen, the rest of the 30 mL of 0.25 % of bupivacaine will be injected
Receives: Procedure: Quadratus lumborum block

What is being measured

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

  1. difference in dynamic visual analog scale (VAS - D) scores at 30 minutes post. - block

    comparison of median reduction in VAS - D scores ( during 15 - degree limb elevation ) between ultrasound - guided pericapsular nerve group block and quadratus lumborum block at 30 minutes after block administration.

    scale: VAS ( 0 - 10 cm; 0 = no pain, 10 = worst pain )

    Measured: baseline ( pre - block ) to 30 minutes post block.

Secondary outcomes (5)
  1. ease of spinal positioning score (EOSP)

    assessed during sitting for spinal anesthesia using a 4 - point ordinal scale

    1. sitting without pain and minimal help.
    2. mild pain detected by grimacing or verbal expression.
    3. severe pain but tolerates positioning with help.
    4. unable to sit, requires additional analgesia)

    Measured: immediately before spinal anesthesia ( 30 minutes post - block )

  2. operator satisfaction score

    rated by the anesthesiologist preforming spinal anesthesia on a 4 - point scale: excellent, good, average, poor

    Measured: immediately after spinal anesthesia placement.

  3. postoperative pain score

    visual analog scale score recorded at: 0 hour postoperative, 2 hour, 4 hour, 6 hour, 12 hour and 24 hour postoperatively.

    Measured: first 24 hours post - surgery

  4. time of first rescue analgesia

    time ( minutes ) from block administration to first request for rescue analgesia ( nalbuphine )

    Measured: up to 24 hours post - block

  5. total rescue analgesia consumption

    cumulative dose of nalbuphine ( mg ) administered in the first 24 hours postoperatively.

    Measured: first 24 hours post - surgery

Timeline

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

  1. First posted9 Apr 2025
  2. Study start10 Apr 2025
  3. Primary completion10 Oct 2025
  4. Study completion10 Jan 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06917807
Sponsor's protocol ID
MD02/2024/2025
Status last verified
Feb 2026
First submitted
6 Mar 2025
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pericapsuler nerve group block and Quadratus lumborum block in people with Acute Post Operative Pain and Hip Fracture, 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 3 inclusion and 9 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 10 Feb 2026. 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?

difference in dynamic visual analog scale (VAS - D) scores at 30 minutes post. - block (time frame: baseline ( pre - block ) to 30 minutes post block.). 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 10 Feb 2026.

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