NCT07194356

Brief Summary

Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. The pericapsular nerve group (PENG) block has recently been introduced as a regional anesthesia technique that targets articular branches of the femoral, obturator, and accessory obturator nerves, and has been proposed as a method to reduce pain related to hip fracture positioning. This study is designed to compare the efficacy of preoperative PENG block versus no block in patients undergoing proximal femoral nailing surgery under spinal anesthesia. The primary objective is to assess its effect on positioning pain using visual analog scale (VAS) scores. Secondary objectives include evaluating its impact on postoperative analgesic consumption, time to first rescue analgesic, and potential side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 10, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

PENG BlockPericapsular Nerve Group BlockHip SurgeryGeriatric AnesthesiaAnalgesiaVisual Analog ScaleTramadolUltrasound-Guided BlockPositioning PainPeripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Pain intensity during positioning for spinal anesthesia

    Pain scores were recorded using the Visual Analog Scale (VAS; 0-10 cm, where 0 = no pain and 10 = worst pain imaginable) during positioning for spinal anesthesia prior to hip fracture surgery.

    During spinal anesthesia positioning (within 15 minutes preoperatively)

Secondary Outcomes (4)

  • Postoperative VAS scores

    0-24 hours after surgery

  • Cumulative tramadol requirement in the first 24 hours

    0-24 hours after surgery

  • Time to first request for rescue analgesia

    0-24 hours after surgery

  • Incidence of adverse events related to anesthesia

    Intraoperative to 24 hours postoperatively

Study Arms (2)

PENG Block Group

EXPERIMENTAL

Patients in this group received an ultrasound-guided Pericapsular Nerve Group (PENG) block prior to spinal anesthesia for hip fracture surgery. The block was performed with local anesthetic injection under ultrasound guidance, targeting the articular branches innervating the anterior hip capsule.

Procedure: Pericapsular nerve group (PENG) block

Control Group

ACTIVE COMPARATOR

Patients in this group did not receive a preoperative nerve block. They underwent spinal anesthesia directly for hip fracture surgery without prior intervention. Pain during positioning and postoperative analgesic requirements were evaluated in comparison to the PENG block group.

Procedure: Standard Spinal Anesthesia (Control)

Interventions

A single-shot PENG block was administered preoperatively using ultrasound guidance. The block was performed with the patient in the supine position, and 20 mL of local anesthetic (0.25% bupivacaine) was injected between the psoas tendon and the superior pubic ramus to achieve analgesia of the anterior hip capsule.

PENG Block Group

Patients in this arm were managed according to standard care protocols for spinal anesthesia in hip fracture surgery. No preoperative regional block was performed. Pain scores and postoperative tramadol use were measured for comparison with the experimental arm.

Control Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 90 years
  • ASA (American Society of Anesthesiologists) physical status classification I-III
  • Scheduled for proximal femoral nailing due to hip fracture
  • Able to provide informed consent (or consent provided by a legal representative)
  • Willingness to comply with study procedures and follow-up assessments

You may not qualify if:

  • \- ASA physical status classification IV or V
  • Refusal to provide informed consent
  • Coagulopathy or current use of anticoagulant therapy contraindicating neuraxial block
  • Local infection at the injection site
  • Known allergy or hypersensitivity to local anesthetic agents
  • Cognitive impairment or inability to cooperate with study procedures
  • Severe psychiatric illness preventing reliable pain assessment
  • Previous surgery or deformity of the hip interfering with block performance
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility Name: Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences

Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip FracturesAgnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Gulcan Gul, M.D.

    Department of Anesthesiology and Reanimation, Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and care providers were not blinded due to the nature of the intervention. However, the outcome assessor who recorded VAS scores and postoperative analgesic consumption was blinded to group assignment to reduce potential bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, parallel-group, controlled trial evaluating the effectiveness of PENG block versus no block in patients undergoing hip fracture surgery under spinal anesthesia.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 26, 2025

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

May 31, 2024

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Plan Description: Individual participant data (IPD) will not be shared because this study was a single-center thesis project with a limited sample size. Only summary-level results and aggregate data will be published in peer-reviewed journals. Patient confidentiality and institutional data protection policies prevent public release of individual-level datasets.

Locations