NCT07350044

Brief Summary

Hip fracture surgery in geriatric patients is frequently associated with severe perioperative pain, which may complicate positioning for spinal anesthesia and increase perioperative opioid requirements. Regional analgesic techniques are commonly used to improve patient comfort and reduce opioid consumption in this vulnerable population. The femoral nerve block is a well-established method for analgesia in hip surgery, while the pericapsular nerve group (PENG) block has emerged as a novel technique targeting articular branches of the hip joint with potential advantages in pain control. This prospective randomized controlled trial aims to compare the analgesic efficacy of femoral nerve block alone versus a combined pericapsular nerve group (PENG) plus femoral nerve block in geriatric patients undergoing hip fracture surgery under spinal anesthesia. The primary outcomes include perioperative pain intensity, opioid consumption within the first 24 hours postoperatively, and the need for additional analgesia during positioning for spinal anesthesia. Secondary outcomes include spinal anesthesia procedure duration, time to sensory block onset, time to first postoperative opioid requirement, and perioperative hemodynamic parameters. The results of this study are expected to clarify whether the addition of the PENG block to femoral nerve block provides superior perioperative analgesia and improved patient comfort compared with femoral nerve block alone in geriatric hip fracture surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

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 Progress82%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

January 5, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

PENG blockFemoral blockHip Fracture SurgeriesPainOpioid

Outcome Measures

Primary Outcomes (1)

  • Pain Score During Positioning for Spinal Anesthesia

    To compare pain intensity during patient positioning for spinal anesthesia between the Femoral Nerve Block group and the combined Pericapsular Nerve Group (PENG) + Femoral Nerve Block group. Pain will be assessed using the Visual Analog Scale (VAS) at the time of lateral decubitus positioning for spinal anesthesia. The need for additional intravenous fentanyl during positioning will also be recorded.

    Periprocedural: from initiation of lateral decubitus positioning for spinal anesthesia to completion of the spinal anesthetic procedure (needle withdrawal following intrathecal injection).

Secondary Outcomes (3)

  • Postoperative Pain Scores Within the First 24 Hours

    Within the first 24 hours postoperatively

  • Total Opioid Consumption Within the First 24 Hours

    Within the first 24 hours postoperatively.

  • Hemodynamic Stability During Perioperative Period

    From block application to 24 hours postoperatively

Study Arms (2)

Femoral Nerve Block

EXPERIMENTAL

Participants will receive a preoperative ultrasound-guided femoral nerve block performed approximately 30 minutes before surgery.

Procedure: Femoral Nerve Block

PENG Block + Femoral Nerve Block

EXPERIMENTAL

Participants will receive a combination of preoperative ultrasound-guided pericapsular nerve group (PENG) block and femoral nerve block performed approximately 30 minutes before surgery.

Procedure: Pericapsular nerve group (PENG) block plus femoral nerve block

Interventions

Combination of ultrasound-guided pericapsular nerve group (PENG) block and femoral nerve block performed preoperatively approximately 30 minutes before surgery using 20 mL of 0.25% bupivacaine for each block for perioperative analgesia.

PENG Block + Femoral Nerve Block

Ultrasound-guided femoral nerve block performed preoperatively approximately 30 minutes before surgery using 20 mL of 0.25% bupivacaine for perioperative analgesia.

Femoral Nerve Block

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years and older,
  • Patients scheduled for surgery due to hip fracture,
  • American Society of Anesthesiologists (ASA) physical status I-III,
  • Body mass index between 18 and 40 kg/m²,
  • Preoperative fasting duration of approximately 8 hours,
  • Planned spinal anesthesia,
  • Ability to provide written informed consent.

You may not qualify if:

  • Age below 65 years,
  • Refusal to participate in the study,
  • Severe cognitive impairment, dementia, or Alzheimer's disease,
  • ASA physical status IV or higher,
  • Body mass index \> 40 kg/m²,
  • Failed spinal anesthesia or conversion to general anesthesia,
  • Revision hip surgery,
  • Multiple trauma patients,
  • Old hip fractures (\>3 weeks),
  • Active malignancy receiving chemotherapy or radiotherapy,
  • Active infection requiring antibiotic treatment (except prophylaxis),
  • Contraindications to regional anesthesia techniques,
  • Chronic steroid or immunosuppressive therapy,
  • Use of anti-inflammatory drugs,
  • Non-fasted patients,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 39514540

    BACKGROUND
  • 38073453

    BACKGROUND
  • PMID: 38073453

    BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Sündüz İlayda Yıldız Akça

CONTACT

Semih Başkan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in parallel to one of two groups. One group will receive a preoperative femoral nerve block, while the other group will receive a combination of preoperative pericapsular nerve group (PENG) block and femoral nerve block. All interventions will be performed before surgery, and participants will be followed for 24 hours postoperatively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Clinical Professor, Anesthesiology and Reanimation, Principal İnvestigator

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 20, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations