SFIB vs PENG Block in the Anesthesia for Total Hip Replacement

NCT07061223 | Enrolling By Invitation

• 1 other identifier: NMSC-02-25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o. Modern approaches of control of general anesthesia allow safe performance of different surgical interventions under general anesthesia. However, general anesthesia does not have an effective and long-lasting effect on relieving operational stress compared to neuraxial anesthesia. To achieve a similar effect, it is necessary to adhere to the principle of multimodality of anesthesia, and the most promising method is a combination of general and regional anesthesia. peripheral blocks are described in the literature, aimed at analgesia directly in the hip joint area, and effectively used in orthopedics. Most blocks are currently performed under ultrasound control, the risk of nerve damage and accidental intravascular administration of local anesthetics is potentially reduced. It was established that the use of ultrasound guidance reduces the number of attempts and the amount of anesthetic administered, as well as reduces the time required to perform a block. Another predicted effect is a reduction in the doses of opioids and non-steroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal bleeding and have a nephrotoxic effect, and can also depress breathing. It should be noted that patients over 65 y.o., have the highest risks of these side effects. This study aims to compare the effectiveness and safety of SFIB and PENG block in hip replacement, as well as evaluation of the effectiveness of combined anesthesia in comparison with general anesthesia without the use of peripheral blocks.

Conditions

Regional Anesthesia; Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total dose of opioid analgesics

  The total amount of consumed fentanyl required for pain relief will be recorded 24 hours after surgery. For this purpose number of fentanyl boluses will be multiplied on dose size for each included patient.

  24 hours after surgery

Study Arms (3)

General anesthesia with SFIB

EXPERIMENTAL

In this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered.

Procedure: SFIB; Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia

General anesthesia with PENG block

EXPERIMENTAL

The block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.

Procedure: PENG block; Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia

Control group with general inhalation anesthesia

OTHER

The control group will undergo general inhalation anesthesia with bolus intraoperative administration of Fentanyl before particularly traumatic stages. For postoperative pain relief, the patient will have the opportunity to use a fentanyl bolus according to the patient-controled analgesia protocol.

Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia

Interventions

SFIB PROCEDURE

The block technique is based on administration of a local anesthetic under the iliac fascia to block the femoral, lateral femoral cutaneous, and obturator nerves. It is assumed that further leakage of local anesthetic through the interfascial space leads to blocking of the branches of the lumbar plexus in the small pelvis.

General anesthesia with SFIB

PENG block PROCEDURE

The hip capsule is the main source of pain because the innervation of the joint capsule is a developed network of articular branches of the femoral, sciatic and obturator nerves. The main idea of this technique is to block these branches at the point of common passage between the tendon of the lumbar muscle and the crest of the pubic bone. The block technique is based on administration of a local anesthetic under the ileo-lumbar tendon. Anesthetic spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.

General anesthesia with PENG block

Patient control analgesia PROCEDURE

In the postoperative period, if pain occurs, the patient will be offered the opportunity to use 20 ug Fentanyl solution bolus according to the patient control analgesia (PCA) without a basic infusion.

Control group with general inhalation anesthesia; General anesthesia with PENG block; General anesthesia with SFIB

General inhalation anaesthesia PROCEDURE

General inhalation anesthesia will be performed in all groups, Desflurane with a minimal alveolar concentration (MAC) of 0.6-0.8 will be used for maintenance

Control group with general inhalation anesthesia; General anesthesia with PENG block; General anesthesia with SFIB

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed, dated informed consent form
• Age from 50 to 75 years
• Indications for primary total hip replacement
• American Society of Anesthesiologists (ASA) score from 1 to 3

You may not qualify if:

• Patients receiving beta blockers;
• Infectious manifestations at the puncture site;
• Bleeding, clinically significant hypovolemia of any origin, shock;
• Disorders of the blood coagulation system;
• Intolerance to local anesthetics;
• Demyelinating diseases of the nervous system;
• Allergy to local anesthetics;
• Psychiatric diseases;
• Any conditions that prevent obtaining informed consent.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 months after completion of the study
• Access Criteria: upon the reasonable request

Locations

RU (1)