Effectiveness Of The Pericapsular Nerve Group (PENG) Block In Hip Surgery

August 9, 2023 updated by: Mustafa Ogurlu, Aydin Adnan Menderes University

Evaluation Of The Postoperative Analgesic Effectiveness Of The Pericapsular Nerve Group Block Performed Before Spinal Anesthesia In Hip Surgery

The target population of hip surgery is usually the elderly patients with systemic comorbidity. Especially hip fractures are common in society and cause high morbidity and mortality for geriatric patients . Pain felt before and during surgery can cause metabolic and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce postoperative complications and mortality and accelerate post-surgical recovery. Pharmacological methods such as opioids and NSAIDs used for this may cause further deterioration and other side effects in geriatric patients with reduced renal and hepatic function, thus delaying post-surgical recovery and thus discharge. In order to avoid these side effects, regional anesthesia techniques can be preferred.

Regional anesthesia techniques are among the most effective methods of postoperative analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods. Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they provide effective analgesia, reduce the need for opioids and consequently their side effects, are effective in the treatment of dynamic pain and facilitate recovery.

Patients undergoing hip surgery have very severe pain and need additional postoperative analgesics. Mobilization of patients is delayed due to pain . Depending on this , thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis , wound infection and increased length of stay.

Alleviating the pain around the hip joint capsule is an effective analgesia method in hip surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator , and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24 hours postoperatively. PENG block is a method that is frequently used in the world and in our clinic and has a low complication rate.

In this study, the investigators aimed to show that pericapsular nerve group block performed before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total opioid consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Mustafa OGURLU, Professor Doctor
  • Phone Number: +905326056932
  • Email: mogurlu@adu.edu.tr

Study Locations

  • Turkey
      • Aydın, Turkey
        • Recruiting
        • Adnan Menderes University Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with written informed consent
  • Patients over 18 years old
  • Patients with ASA score I-II-III
  • Patients performed spinal anesthesia for surgery

Exclusion Criteria:

  • Patients without written informed consent
  • Patients with ASA score IV and above
  • Patients who cannot be communicated
  • Patients with infection at the block site
  • Patients with coagulation disorders
  • Patients not suitable for spinal anesthesia
  • Patients with liver and kidney failure
  • Patients who are allergic to the drugs used
  • Patients with major complications during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Active Comparator: PENG
PENG block performed before spinal anesthesia
Drug: PENG block
The PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Preoperative
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Preoperative
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: During the spinal anesthesia
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
During the spinal anesthesia
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Postoperative 0. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Postoperative 0. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Postoperative 1. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Postoperative 1. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Postoperative 6. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Postoperative 6. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Postoperative 12. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Postoperative 12. hour
Numeric Rating Scale (NRS) for postoperative analgesic efficacy
Time Frame: Postoperative 24. hour
NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
Postoperative 24. hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amounts of postoperative analgesic consumption
Time Frame: Postoperative 24 hours
Postoperative analgesic consumption amounts will be compared between the patients performed PENG block and the control group.
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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