Skip to main content
OpenTrials
Completed

NCT Number: NCT07194356

Effect of Preoperative PENG Block on Spinal Anesthesia Positioning and Postoperative Analgesia in Hip Fracture Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Fractures (ICD-10 72.01-72.2) Agnosia Elderly Patients Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Pain Management After Total Hip Arthroplasty Regional Anesthesia Signs and Symptoms Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34890, Turkey (Türkiye)

About this study

This is a prospective, single-center, randomized controlled trial conducted at the University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital. A total of 60 patients, aged 18-90 years, with ASA I-III status, scheduled for proximal femoral nailing (PFN) surgery due to hip fracture, were enrolled. Patients were randomized into two groups using a sealed-envelope method:

PENG Block Group: Received a preoperative ultrasound-guided pericapsular nerve group (PENG) block 30 minutes before spinal anesthesia.

Control Group: Received no block prior to spinal anesthesia.

Standard spinal anesthesia was performed in both groups. All patients received intravenous paracetamol for postoperative analgesia at regular intervals. Additional analgesia with intravenous tramadol was administered if VAS ≥ 4.

The following parameters were collected:

Demographics (age, sex, BMI, ASA status, comorbidities)

Hemodynamic variables (SBP, DBP, HR, SpO₂) at baseline and during perioperative period

VAS scores at baseline, during positioning, and at postoperative time intervals (0, 15, 30 minutes, and 1, 2, 6, 12, and 24 hours)

Time to first rescue analgesic

Total opioid consumption in the first 24 hours postoperatively

Side effects such as nausea, vomiting, or other complications

The study aims to test the hypothesis that PENG block can reduce pain during positioning for spinal anesthesia and may improve postoperative analgesia in patients undergoing hip fracture surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • - 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

Treatment and study plan

pericapsular nerve group (PENG) block

Procedure

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.

Standard Spinal Anesthesia (Control)

Procedure

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.

Primary outcomes

  1. Pain intensity during positioning for spinal anesthesia

    Time frame: During spinal anesthesia positioning (within 15 minutes preoperatively)

    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.

Secondary outcomes

  1. Postoperative VAS scores

    Time frame: 0-24 hours after surgery

    Pain scores were assessed using the Visual Analog Scale (VAS) at 2, 6, 12, and 24 hours postoperatively.

  2. Cumulative tramadol requirement in the first 24 hours

    Time frame: 0-24 hours after surgery

    The total dose of intravenous tramadol administered for breakthrough pain was recorded for each patient.

  3. Time to first request for rescue analgesia

    Time frame: 0-24 hours after surgery

    The duration (in hours) between the end of surgery and the first administration of rescue tramadol was recorded.

  4. Incidence of adverse events related to anesthesia

    Time frame: Intraoperative to 24 hours postoperatively

    Frequency of side effects such as nausea, vomiting, hypotension, and local anesthetic systemic toxicity were documented.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Effect of Preoperative Pericapsular Nerve Group (PENG) Block on Positioning for Spinal Anesthesia and Postoperative Analgesia in Patients Undergoing Hip Fracture Surgery

Acronym: PENG-SPINE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.