- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06777953
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
Completed
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Anti-Arrhythmia Agents
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Membrane Transport Modulators
- Bupivacaine
- Lidocaine
Other Study ID 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.
Clinical Trials on Erector Spinae Plane Block
-
Aycan KURTARANGİL DOĞANKutahya City HospitalNot yet recruitingLaparoscopic Cholecystectomy | Erector Spinae Plane Block | Plane Block
-
Medical University of WarsawCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityRecruiting
-
Harran UniversityCompletedErector Spinae Plane BlockTurkey
-
Nanjing First Hospital, Nanjing Medical UniversityRecruiting
-
Medical University of WarsawWarsaw Clinical University CenterUnknown
-
Tanta UniversityRecruitingErector Spinae Plane Block | Arthroscopy | Interscalene BlockEgypt
-
Kafrelsheikh UniversityCompletedErector Spinae Plane Block | Radical CystectomyEgypt
-
Tanta UniversityRecruitingSurgery | Erector Spinae Plane Block | Cardiac | Recto-intercostal Fascial Plane Block | Pecto-intercostal Fascial Plane BlockEgypt
-
Port Said University hospitalCompletedErector Spinae Plane Block | Quadratus Lumborum Block | Sleeve GastrectomyEgypt
Clinical Trials on Erector Spinae (ESP) Block with Lidocaine/Bupivacaine
-
RenJi HospitalNot yet recruitingPain, Postoperative | Regional Anesthesia Morbidity
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruiting
-
Başakşehir Çam & Sakura City HospitalRecruitingPain, Postoperative | Opioid Use | Respiratory Function LossTurkey
-
Indonesia UniversityCompletedChronic Post Operative Pain | Laparoscopy | Kidney Transplant; Complications | Anesthesia RegionalIndonesia
-
University Health Network, TorontoRecruiting
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingPostoperative Pain | Surgical Blood Loss | Lumbar Spinal Fusion SurgerySpain
-
Antalya City HospitalNot yet recruitingPostoperative Pain | Erector Spine Plane Block | Intertransverse Process Block | Robotic Colorectal SurgeryTurkey (Türkiye)
-
Harran UniversityCompletedPain, Postoperative | Cholecystectomy, Laparoscopic | Electrocardiography | Regional Anesthesia | Cardiac ElectrophysiologyTurkey (Türkiye)
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...Not yet recruitingPostoperative Pain | Thoracic Surgery, Video Assisted
-
Zagazig UniversityCompletedPostoperative Pain ManagementEgypt