The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery

April 30, 2024 updated by: Antalya Training and Research Hospital

The Effect of Ultrasound-guided Pericapsular Nerve Block, Fascia Iliaca Compartment Block and Femoral Block on Postoperative Recovery Quality in Hip Surgery

The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.

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

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.

Detailed Description

Orthopedic procedures have become increasingly common in clinical practice. With the increasing elderly population, there have been significant developments in recent years in the field of perioperative pain management and anesthesia strategies for patients scheduled for hip surgery. Patients undergoing hip surgery may experience severe pain both postoperatively and during the positioning of the patient during surgery. This leads to increased sympathetic activation such as tachycardia and hypertension in patients, especially in the elderly population, and some undesirable complications due to the patients' existing comorbidities. Therefore, pain management strategies for patients undergoing hip surgery are based on a range of anesthesia techniques, including the use of opioids, neuraxial anesthesia (spinal, epidural, or a combination of them), nerve blocks, especially pericapsular nerve block (PENG), fascia iliaca compartment block (FICB) and femoral block). Reducing patients' pain and improving the quality of postoperative recovery has become increasingly important. The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The aim of this study was to evaluate the effect of ultrasound-guided PENG block, FICB block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia.

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.
Observational

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.
80

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 Locations

  • Turkey
      • Antalya, Turkey
        • Recruiting
        • University of Health Sciences, Antalya Training and Researh Hospital
        • Contact:
          • Antalya Training and Research Hospital

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

Sampling Method

Non-Probability Sample

Study Population

It is planned to include ASA I-III patients between the ages of 1-85 who are planned to undergo hip fracture surgery under elective spinal anesthesia.

Description

Inclusion Criteria:

  • elective hip fracture,
  • 18-85 years
  • American Society of Anaesthesiology (ASA) I-III

Exclusion Criteria:

  • patients planned for general anesthesia
  • with multiple fractures
  • bleeding disorder
  • peripheral neuropathy
  • mental disorder
  • local anesthetic allergy
  • contraindications for spinal anesthesia (local infection, etc.)
  • declining to give written informed consent

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
PENG block group
Before the spinal anesthesia, PENG block will be performed under the guidance of ultrasound.
Other: PENG block group
Ultrasound-guided PENG block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
FIC block group
Before the spinal anesthesia, FIC block will be performed under the guidance of ultrasound.
Other: FIC block group
Ultrasound-guided FIC block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Femoral block group
Before the spinal anesthesia, femoral block will be performed under the guidance of ultrasound.
Other: Femoral block group
Ultrasound-guided femoral block is performed approximately 30 minutes before surgery in patients undergoing hip surgery in a separate regional anaesthesia room with standard anaesthesia monitoring.
Control group
No intervention
Other: Control group
No intervention

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
recovery quality
Time Frame: 5 minutes
The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess postoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the early postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points,
5 minutes

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
postoperative Numeric Rating Scale (NRS) pain score
Time Frame: postoperative 24 hours
The postoperative pain intensity will be assessed with Numeric Rating Scale (NRS) scores (0 represents no pain and 10 represents the worst possible pain) at postoperative 24 hours.
postoperative 24 hours
postoperative opioid consumption
Time Frame: postoperative 24 hours
The amount of postoperative opioid consumption will be recorded
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.
Antalya Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arzu Karaveli, M.D., University of Health Sciences, Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
April 30, 2024

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.
September 24, 2024

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.
October 24, 2024

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).
April 24, 2024

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.
April 24, 2024

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.
April 29, 2024

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.
May 1, 2024

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.
April 30, 2024

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.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2023-18/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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