NCT07467356

Brief Summary

Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures.The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
4mo left

Started Mar 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Pain Management

Keywords

PENG blockanterior iliopsoas space blockease of positioninghip surgeries

Outcome Measures

Primary Outcomes (1)

  • the ease of spinal positioning

    EOSP will be assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain)

    30 minutes after block

Secondary Outcomes (3)

  • VAS at rest and on passive 15° limb lifting

    30 minutes after block 2 hours postoperatively 6 hours postoperatively 12 hours postoperatively 24 hours postoperatively

  • amount of pethidine intake

    24 hours postoperatively

  • quality of recovery score

    24 hours after surgery

Study Arms (2)

Group (P)

ACTIVE COMPARATOR

patients will receive PENG block(using bupivacaine 0.20% 25ml).

Drug: Bupivacaine

Group (A)

ACTIVE COMPARATOR

patients will receive anterior ilio-psoas space block(using bupivacaine 0.20% 25ml).

Drug: Bupivacaine

Interventions

BupivacaineDRUG

The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.

Group (P)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (ASA )classes I and II
  • patients of either sex, above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours

You may not qualify if:

  • patient's refusal to participate
  • any contraindications to SA or peripheral nerve blocks
  • history of ischemic heart disease
  • patients on opioids for chronic pain
  • patients with significant cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

fatma ahmed abdelfatah, MD

CONTACT

00201091921540drfatmaahmed86@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

EG(1)