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

Primary Purpose

Pain, Postoperative, Anesthesia, Regional, Hip Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lumbar Erector Spinae Plane Block
Pericapsular Nerve Group Block
no peripheral block
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring Hip Surgery, Pericapsular Nerve Group Block, Lumbar Erector Spinae Plane Block, Regional Anesthesia, Ultrasound-Guided

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trakya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Group (no peripheral block applied)

Lumbar Erector Spinae Plane Block (L-ESPB) Group

Pericapsular Nerve Group Block (PENGB) Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Additional Analgesia
Analgesic drugs administered in the first 24 hours in addition to the routine multimodal analgesia procedure were recorded.
5-point likert satisfaction scale
The patient's satisfaction with postoperative pain treatment will be recorded. 5 options; very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied, very satisfied

Full Information

First Posted
March 25, 2023
Last Updated
June 14, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05802589
Brief Title
Comparison of the Efficiency of PENG Block and ESP Block Used for Postoperative Analgesia in Elective Hip Surgery
Official Title
Comparison of the Efficiency of Pericapsular Nerve Group Block and Unilateral Lumbar Erector Spina Plan Block Used for Postoperative Analgesia in Elective Hip Surgery: A Prospective Randomized Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Regional, Hip Surgery, Ultrasound-Guided
Keywords
Hip Surgery, Pericapsular Nerve Group Block, Lumbar Erector Spinae Plane Block, Regional Anesthesia, Ultrasound-Guided

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was designed as a randomized, double-blind, prospective efficacy study.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (no peripheral block applied)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lumbar Erector Spinae Plane Block (L-ESPB) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pericapsular Nerve Group Block (PENGB) Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Erector Spinae Plane Block
Intervention Description
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
Intervention Name(s)
Pericapsular Nerve Group Block
Intervention Description
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
Intervention Name(s)
no peripheral block
Intervention Description
No peripheral block was applied. Standard multimodal analgesia method was applied.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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.
Time Frame
postoperative 24 hours score change
Secondary Outcome Measure Information:
Title
Additional Analgesia
Description
Analgesic drugs administered in the first 24 hours in addition to the routine multimodal analgesia procedure were recorded.
Time Frame
postoperative 24 hours additional analgesic drug administration
Title
5-point likert satisfaction scale
Description
The patient's satisfaction with postoperative pain treatment will be recorded. 5 options; very dissatisfied, dissatisfied, neither dissatisfied or satisfied, satisfied, very satisfied
Time Frame
postoperative 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ONUR KÜÇÜK, specialist
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University
City
Edirne
State/Province
Centrum
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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