NCT06917807

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

March 6, 2025

Last Update Submit

February 8, 2026

Conditions

Keywords

regional anesthesiapain managmentQLB blockPENG blockHip fracturepostoperative analgesianerve blockopioid sparing anesthesiaacute pain controlclinical trial

Outcome Measures

Primary Outcomes (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 )

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

Secondary Outcomes (5)

  • ease of spinal positioning score (EOSP)

    immediately before spinal anesthesia ( 30 minutes post - block )

  • operator satisfaction score

    immediately after spinal anesthesia placement.

  • postoperative pain score

    first 24 hours post - surgery

  • time of first rescue analgesia

    up to 24 hours post - block

  • total rescue analgesia consumption

    first 24 hours post - surgery

Study Arms (2)

Pericapsular nervegroup block

ACTIVE COMPARATOR

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 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)

Procedure: Pericapsuler nerve group block

Quadratus lumborum block

ACTIVE COMPARATOR

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, 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

Procedure: Quadratus lumborum block

Interventions

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

Pericapsular nervegroup block

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

Quadratus lumborum block

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, Abassya, 00202, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeHip Fractures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

April 9, 2025

Study Start

April 10, 2025

Primary Completion

October 10, 2025

Study Completion

January 10, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations