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

Study Type

Observational

Enrollment (Actual)

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

      • 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

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
Intervention / Treatment
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.
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.
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

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

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.

Investigators

  • 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)

November 1, 2024

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

December 28, 2024

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

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.

Clinical Trials on Erector Spinae Plane Block

Clinical Trials on Erector Spinae (ESP) Block with Lidocaine/Bupivacaine

Subscribe