Erector Spinae Plane BlockNCT06777953
Regional Anesthesia for Lower Extremity Surgery
An observational study of Erector Spinae Plane Block and Lower Extremity Surgery, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Lower Extremity Surgery, Sciatic Nerve Block
- What is being tested?
- Erector Spinae (ESP) Block with Lidocaine/Bupivacaine and Popliteal Sciatic Nerve Block
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 28 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proximal tibial fractures who underwent surgery within the past year at the orthopedic clinic.
Who may be able to join
- Patients aged 18-65
- Patients undergoing spinal anesthesia
- Patients undergoing postoperative erector spinae plane block
- Patients undergoing postoperative sciatic nerve block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, 34265
About this study
Official title: 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.
- Being tested
- Erector Spinae (ESP) Block with Lidocaine/Bupivacaine, Popliteal Sciatic Nerve Block
- Keywords
- sacral erector spinae plane block, lower extremity surgery, lumbar erector spinae plane block, sciatic nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae (ESP) Block with Lidocaine/BupivacaineOther
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.
Popliteal Sciatic Nerve BlockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Erector Spinae (ESP) Block with Lidocaine/Bupivacaine | |
| 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. Receives: Other: Popliteal Sciatic Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Analgesia
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.
Measured: 24 hours
Secondary outcomes (1)
Block related complication
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Nov 2024
- Primary completion15 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munevver Kayhan, Medical Doctor, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777953
- Sponsor's protocol ID
- HEA-AAR-MK-03
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Popliteal Sciatic Nerve and Lumbar Sacral Erector Spinae Plane Blocks for Postoperative Analgesia in Tibia Fractures: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06777953
- Acronym / sponsor ID
- HEA-AAR-MK-03
- Keywords
- sacral erector spinae plane block, lower extremity surgery, lumbar erector spinae plane block, sciatic nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | – | Other: Erector Spinae (ESP) Block with Lidocaine/BupivacainePatients 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. |
| Sciatic Nerve Plane Block Group | – | Other: Popliteal Sciatic Nerve BlockPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proximal tibial fractures who underwent surgery within the past year at the orthopedic clinic.
Key inclusion criteria (4 listed)
- Patients aged 18-65
- Patients undergoing spinal anesthesia
- Patients undergoing postoperative erector spinae plane block
- Patients undergoing postoperative sciatic nerve block
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae (ESP) Block with Lidocaine/BupivacaineThis 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. | Other | Erector Spinae Plane Block Group |
| Popliteal Sciatic Nerve BlockThis 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. | Other | Sciatic Nerve Plane Block Group |
Primary outcome
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.
1 secondary outcome
Block related complication
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munevver Kayhan, Medical Doctor principal investigator
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erector Spinae Plane Block and Lower Extremity Surgery, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.