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

NCT ID: NCT07194356

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-05-31

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.

Detailed Description

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.

Conditions

Hip Fractures (ICD-10 72.01-72.2); Postoperative Pain Management After Total Hip Arthroplasty; Elderly Patients; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PENG Block Group

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.

Group Type: EXPERIMENTAL

Pericapsular nerve group (PENG) block

Intervention Type: 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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Spinal Anesthesia (Control)

Intervention Type: 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.

Interventions

Pericapsular nerve group (PENG) block

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.

Intervention Type: PROCEDURE

Standard Spinal Anesthesia (Control)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gülcan GÜL

Specialist in Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulcan Gul, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/514/261/14

Identifier Type: OTHER

Identifier Source: secondary_id

KLKSH-ANES-PENG-001

Identifier Type: -

Identifier Source: org_study_id