Regional Anesthesia for Lower Extremity Surgery

January 10, 2025 updated by: Haseki Training and Research Hospital

Comparative Efficacy of Popliteal Sciatic Nerve and Lumbar Sacral Erector Spinae Plane Blocks for Postoperative Analgesia in Tibia Fractures: a Retrospective Cohort Study

In this study, patients who underwent osteosynthesis with plate via standard anterolateral incision due to proximal tibia fracture in the orthopedic clinic within the last year; those who underwent perioperative anesthesia with spinal block, those who underwent postoperative analgesia with Ultrasound-guided popliteal sciatic nerve block, lumbar-sacral Erector Spine plane block combinations in the recovery unit will be identified and their files will be scanned retrospectively. Gender, surgical duration, postoperative block, pre-post block pain levels will be reviewed via Visual Analog Scale scoring, postoperative analgesics consumed and their amounts, Bromage scale, mobilization times, block-related complications, satisfaction levels will be determined and these two groups of patients who underwent block will be compared in terms of analgesia, complications, and satisfaction.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
32

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34265
        • Haseki 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

Patients with proximal tibial fractures who underwent surgery within the past year at the orthopedic clinic.

Description

Inclusion Criteria:

  • Patients aged 18-65
  • Patients undergoing spinal anesthesia
  • Patients undergoing postoperative erector spinae plane block
  • Patients undergoing postoperative sciatic nerve block

Exclusion Criteria:

  • Pregnant patients
  • Patients who cannot be contacted
  • Patients who have undergone perioperative general anesthesia
  • Patients with a history of cerebrovascular disease
  • Patients with data loss
  • Patients who did not receive 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.
Erector Spinae Plane Block Group
Patients who underwent spinal anesthesia due to tibial fracture will be identified from their follow-up files. Among these patients, those who underwent erector spinae plane block with 20 ml of 0.5% bupivacaine and 5 ml of 1% lidocaine at the sacral level and 20 ml of 0.5% bupivacaine and 5 ml of 1% lidocaine at the L3 level while sitting under ultrasound guidance for postoperative analgesia will constitute this group.
Other: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine
This study is to retrospectively compare the analgesic efficacy and impact on postoperative recovery of popliteal sciatic nerve blocks and Lumbar-Sacral Erector Spinae Plane blocks administered for postoperative pain management in tibial fractures.
Sciatic Nerve Plane Block Group
Patients who underwent spinal anesthesia due to tibial fracture will be identified from their follow-up files. Among these patients, those who underwent popliteal sciatic nerve block with 30 ml of 0.5% bupivacaine while supine position under ultrasound guidance for postoperative analgesia will constitute this group.
Other: Popliteal Sciatic Nerve Block
This study is to retrospectively compare the analgesic efficacy and impact on postoperative recovery of popliteal sciatic nerve blocks and Lumbar-Sacral Erector Spinae Plane blocks administered for postoperative pain management in tibial fractures.

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
Postoperative Analgesia
Time Frame: 24 hours
Postoperative analgesia will be assessed by Visual Analog Scale Score and postoperative analgesic consumption. The visual analog scale is a numerical assessment ranging from 0 to 10. A score of 0 is considered as no pain, a score of 5 is considered as moderate pain, and a score of 10 is considered as unbearable pain. Rescue intravenous analgesic treatment is applied to scores of 4 and above.
24 hours

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
Block related complication
Time Frame: 24 hours
Patients will be evaluated with Bromage Scale and mobilization times.The bromage scale is a numerical assessment ranging from 0 to 3. A score of 0 is No motor block, a score of 1 is Inability to raise extended leg; able to move knees and feet no pain, a score of 2 is Inability to raise extended leg and move knee; able to move feet, a score of 3 is Complete block of motor limb.It will also be checked when the patients can walk after the motor block has passed.
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.
Haseki 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: Munevver Kayhan, Medical Doctor, Haseki Training and Research Hospital

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.
November 1, 2024

Primary Completion (Actual)

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.
December 15, 2024

Study Completion (Actual)

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.
December 28, 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).
January 4, 2025

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.
January 10, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
January 10, 2025

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.
January 1, 2025

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.
  • HEA-AAR-MK-03

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

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings