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

NCT05802589 | Completed DMC

• 1 other identifier: TÜTF-BAEK 2021/225
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hip Surgery; Pericapsular Nerve Group Block; Lumbar Erector Spinae Plane Block; Regional Anesthesia; Ultrasound-Guided

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  NRS was used to assess postoperative pain. The NRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-10 integer) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It is an 11-point numerical scale. It ranges from "0" representing no pain to "10" representing extreme pain.

  postoperative 24 hours score change

Secondary Outcomes (2)

• Additional Analgesia

  postoperative 24 hours additional analgesic drug administration

• 5-point likert satisfaction scale

  postoperative 24th hour

Study Arms (3)

Control Group (no peripheral block applied)

ACTIVE COMPARATOR

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.

Procedure: no peripheral block

Lumbar Erector Spinae Plane Block (L-ESPB) Group

ACTIVE COMPARATOR

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.

Procedure: Lumbar Erector Spinae Plane Block

Pericapsular Nerve Group Block (PENGB) Group

ACTIVE COMPARATOR

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.

Procedure: Pericapsular Nerve Group Block

Interventions

Lumbar Erector Spinae Plane Block 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.

Lumbar Erector Spinae Plane Block (L-ESPB) Group

Pericapsular Nerve Group Block 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.

Pericapsular Nerve Group Block (PENGB) Group

no peripheral block PROCEDURE

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

Control Group (no peripheral block applied)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ONUR KÜÇÜK, specialist

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Before surgery, patients were given a random number and all data were collected using this number. Group assignments were determined using simple randomization using the closed envelope technique. All data were collected blindly. The blocks were performed by the authors who did not play any role in data collection or analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Research Assistant

Model Details: This study was designed as a randomized, double-blind, prospective efficacy study.

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 6, 2023
• Study Start: May 17, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)