Pain, PostoperativeNCT04642625
Comparison of Ultrasound-guided Bilateral ESP Block and Wound Infiltration for Spinal Surgical Analgesia
An observational study of Pain, Postoperative and Spinal Disease, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Spinal Disease, Anesthesia, Local
- What is being tested?
- Visual Analog Score and patient satisfaction
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. 75 patients meeting these conditions will be included in the study.
Who may be able to join
- Undergoing elective spine surgery
- No contraindication to the technique to be applied
- Not pregnant
- Being over the age of 18
Who cannot join
- Undergoing emergency spine surgery
- There is an obstacle to the technical process to be applied
- Pregnant patients
- Patients younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-guided Bilateral Erector Spinae Plane Block and Wound Infiltration for Spinal Surgical Analgesia
The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.
Read the detailed description
Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. In this study, patient data will be collected in the form of file scanning. Intra-operative; hemodynamic data of patients; heart rate, blood pressure values, anesthetic and other drugs applied, surgery and anesthesia durations will be written from the anesthesia document after the operation is over. In the study, the application preferred by the anesthesiologist for the patient will not be intervened. The patients will be divided into three groups; wound infiltration technique was applied, ultrasound-guided bilateral erector spina plan block technique was applied and both techniques were applied together. After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients. The patient's length of stay, satisfaction (excellent, good, moderate, poor) and methods used for analgesia will be recorded. With the results collected in our study, it will be determined which procedure is superior in pain management for spine surgery.
- Being tested
- Visual Analog Score, patient satisfaction
- Keywords
- ultrasound-guided bilateral erector spina plane block, wound infiltration analgesia, spinal surgery
- Medical subject headings
- Pain, Postoperative, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analog ScoreOther
Also called VAS
The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain".
patient satisfactionOther
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
| Study group | Role | What they receive |
|---|---|---|
| wound infiltration analgesia | 25 patients who underwent wound infiltration analgesia Receives: Other: Visual Analog Score; Other: patient satisfaction | |
| ultrasound-guided bilateral erector spina plan block analgesia | 25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia Receives: Other: Visual Analog Score; Other: patient satisfaction | |
| wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together | 25 patients who underwent wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia Receives: Other: Visual Analog Score; Other: patient satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
It consists of a 100mm line. 0cm no pain, 10cm is associated with 'worst possible pain'. The patient is asked to mark a line to 'score' the pain. VAS values of 1cm-3cm weak, 4cm-6cm moderate, and >7cm are the indicators of "severe pain".After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients.
Measured: postoperative 24 hours score change
Secondary outcomes (1)
patient satisfaction
The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
Measured: postoperative 24 hours score change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Apr 2021
- Primary completion1 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kucuk, Trakya University
- Investigators
- SEVTAP HEKİMOĞLU ŞAHİN, Professor, Principal investigator, Trakya UniversityONUR KÜÇÜK, Resident, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642625
- Sponsor's protocol ID
- TÜTF-BAEK 2020/183
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Bilateral Erector Spinae Plane Block and Wound Infiltration for Spinal Surgical Analgesia
- ClinicalTrials.gov ID
- NCT04642625
- Acronym / sponsor ID
- TÜTF-BAEK 2020/183
- Keywords
- ultrasound-guided bilateral erector spina plane block, wound infiltration analgesia, spinal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 Nov 2020 (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.
The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.
Detailed description
Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. In this study, patient data will be collected in the form of file scanning. Intra-operative; hemodynamic data of patients; heart rate, blood pressure values, anesthetic and other drugs applied, surgery and anesthesia durations will be written from the anesthesia document after the operation is over. In the study, the application preferred by the anesthesiologist for the patient will not be intervened. The patients will be divided into three groups; wound infiltration technique was applied, ultrasound-guided bilateral erector spina plan block technique was applied and both techniques were applied together. After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients. The patient's length of stay, satisfaction (excellent, good, moderate, poor) and methods used for analgesia will be recorded. With the results collected in our study, it will be determined which procedure is superior in pain management for spine surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| wound infiltration analgesia | – | Other: Visual Analog Score, Other: patient satisfaction25 patients who underwent wound infiltration analgesia |
| ultrasound-guided bilateral erector spina plan block analgesia | – | Other: Visual Analog Score, Other: patient satisfaction25 patients who underwent ultrasound-guided bilateral erector spina plan block analgesia |
| wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together | – | Other: Visual Analog Score, Other: patient satisfaction25 patients who underwent wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya University Faculty of Medicine, Brain and Nerve Surgery will be included. 75 patients meeting these conditions will be included in the study.
Key inclusion criteria (4 listed)
- Undergoing elective spine surgery
- No contraindication to the technique to be applied
- Not pregnant
- Being over the age of 18
Key exclusion criteria (4 listed)
- Undergoing emergency spine surgery
- There is an obstacle to the technical process to be applied
- Pregnant patients
- Patients younger than 18 years old
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 |
|---|---|---|
| Visual Analog ScoreAlso: VASThe VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain". | Other | ultrasound-guided bilateral erector spina plan block analgesia, wound infiltration analgesia, wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together |
| patient satisfactionThe patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad. | Other | ultrasound-guided bilateral erector spina plan block analgesia, wound infiltration analgesia, wound infiltration and ultrasound-guided bilateral erector spina plan block analgesia both together |
Primary outcome
Visual Analog Score
Time frame: postoperative 24 hours score change
It consists of a 100mm line. 0cm no pain, 10cm is associated with 'worst possible pain'. The patient is asked to mark a line to 'score' the pain. VAS values of 1cm-3cm weak, 4cm-6cm moderate, and >7cm are the indicators of "severe pain".After the operation; pain values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients.
1 secondary outcome
patient satisfaction
Time frame: postoperative 24 hours score change
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 19 Jan 2023.
- 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.
SEVTAP HEKİMOĞLU ŞAHİN, Professor principal investigator
Trakya University
ONUR KÜÇÜK, Resident principal investigator
Trakya University
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 Pain, Postoperative and Spinal Disease, run by Trakya University 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 4 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 19 Jan 2023. 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?
Visual Analog Score (time frame: postoperative 24 hours score change). 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 19 Jan 2023.