Comparison of the Efficiency of PENG Block and ESP Block Used for Postoperative Analgesia in Elective Hip Surgery

NCT ID: NCT05802589

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2023-06-01

Brief Summary

The aim of the study is to determine whether the traditional intravenous analgesia technique or the ultrasound-guided pericapsular nerve group block or the unilateral erector spina plane block technique is superior in postoperative analgesia management in the hip operation procedure that requires preoperative and postoperative severe analgesia. In this way, by preventing the health problems that may occur due to the pain of the patients after the operation; to provide benefits for the early mobilization of patients, shortening the hospital stay, reducing the cost and increasing patient satisfaction.

Detailed Description

Hip arthroplasty (HA) is one of the most successful orthopedic procedures applied today to improve the patient's functional status and quality of life. In patients with hip pain due to various conditions, HA can relieve pain, restore function, and improve quality of life. In the USA alone, approximately 500,000 HA is performed each year. With the increase in the elderly population, HA surgeries have also increased, but despite the developing methods, a gold standard has not been determined for anesthesia and analgesia methods. Appropriate pain management for surgical patients contributes to early mobilization, shortened hospital stay, reduced cost and increased patient satisfaction, while inadequate treatment of pain has detrimental short- or long-term health effects. Therefore, minimizing postoperative pain has become more important for healthcare providers in recent years. Therefore, postoperative pain control can be achieved with balanced and effective analgesia. For this purpose, various analgesia techniques have been used to prevent postoperative pain. The superiority of the techniques to each other varies according to the type of surgery and the combination of techniques applied. Opioids, which are the most widely used to prevent inadequate pain treatment leading to various comorbidities, cause pharmacodynamic results due to physiological changes and serious side effects due to concomitant diseases in patients. In recent years, peripheral nerve blocks have been used in the management of postoperative pain in hip surgeries. Erector spina plane block and pericapsular nerve group block are the most reliable and proven blocks used in hip operations.

The aim of the study is to determine whether traditional intravenous analgesia technique, ultrasound-guided pericapsular nerve group block or unilateral erector spina plane block technique is superior in postoperative analgesia management in hip operation procedure requiring preoperative and postoperative severe analgesia.

Conditions

Pain, Postoperative; Anesthesia, Regional; Hip Surgery; Ultrasound-Guided

Study Design

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

Study Groups

Control Group (no peripheral block applied)

No peripheral block was applied to this group and it was accepted as the control group. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group.

Group Type: ACTIVE_COMPARATOR

no peripheral block

Intervention Type: PROCEDURE

No peripheral block was applied. Standard multimodal analgesia method was applied.

Lumbar Erector Spinae Plane Block (L-ESPB) Group

Lumbar erector spinae plane block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group.

Group Type: ACTIVE_COMPARATOR

Lumbar Erector Spinae Plane Block

Intervention Type: PROCEDURE

Erector spinae plane block was applied with a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) using in-plane technique using a convex USG transducer from the 4th lumbar vertebral level.

Pericapsular Nerve Group Block (PENGB) Group

Pericapsular nerve group block was applied to this group under ultrasound guidance. Standard multimodal analgesia and rescue analgesia according to NRS score were applied to each group.

Group Type: ACTIVE_COMPARATOR

Pericapsular Nerve Group Block

Intervention Type: PROCEDURE

Pericapsular nerve group block was performed using a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) and a convex USG transducer using an in-plane technique under the iliopsoas muscle in the plane between the iliopsoas tendon and the periosteum and between the anterior inferior iliac spine and the iliopubic eminence.

Interventions

Lumbar Erector Spinae Plane Block

Erector spinae plane block was applied with a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) using in-plane technique using a convex USG transducer from the 4th lumbar vertebral level.

Intervention Type: PROCEDURE

Pericapsular Nerve Group Block

Pericapsular nerve group block was performed using a 22G/80 mm block needle (Stimuplex A, Braun, Melsungen, Germany) and a convex USG transducer using an in-plane technique under the iliopsoas muscle in the plane between the iliopsoas tendon and the periosteum and between the anterior inferior iliac spine and the iliopubic eminence.

Intervention Type: PROCEDURE

no peripheral block

No peripheral block was applied. Standard multimodal analgesia method was applied.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective hip or proximal femoral surgery
• 18-89 years old
• Patients with the American Society of Anesthesiology physical condition classification score (ASA) I-III

Exclusion Criteria

• Patients who do not agree to consent
• Patients who requested to be excluded from the study
• Patients allergic to local anesthetics
• Those with infection at the intervention site
• Those who weigh <30 kg
• Those aged <18 years
• Those with an ASA physical condition of 4 or higher
• People with dementia or cognitive impairment
• Patients with bleeding diathesis pathology
• Patients using chronic opioids or corticosteroids
• Patients whose surgical procedure takes <60 minutes or >180 minutes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Onur Kucuk

Department of anesthesiology and reanimation, Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ONUR KÜÇÜK, specialist

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

Trakya University

Edirne, Centrum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TÜTF-BAEK 2021/225

Identifier Type: -

Identifier Source: org_study_id