BlockNCT04548076
Thoracolumbar Interfascial Plane Block in Vertebral Surgery
An observational study of Block, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
To determine the postoperative analgesic efficiency of thoracolumbar interfascial plane block , patients are divided into two groups. Study group received ultrasound-guided thoracolumbar interfascial plane block , where control had none. Visual analog scale and opioid consumption are recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Block
- What is being tested?
- Block group
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2020to 7 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vertebral surgery patients who will be operated under general anesthesia.
Who may be able to join
- Over 18 years of age, Planned to vertebral surgery, An American Society of Anesthesiologists score of 1,2 or 3
Who cannot join
- Severe cardiovascular disease, Psychiatric diseases, Rejected to participation, Those who have chronic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: Investigation of Analgesic Efficacy of Thoracolumbar Interfascial Plane Block in Vertebral Surgery
To determine the postoperative analgesic efficiency of thoracolumbar interfascial plane block , patients are divided into two groups. Study group received ultrasound-guided thoracolumbar interfascial plane block , where control had none. Visual analog scale and opioid consumption are recorded.
Read the detailed description
Thoracolumbar interfascial plane block has successfully been demonstrated to provide an efficient analgesia in patients. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of thoracolumbar interfascial plane block in patients with vertebral surgery. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.
In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS>4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS>4 the same dose will be repeated. A patient satisfaction questionnaire (Qr40)will be filled by patients at the postoperative 24th hour.
- Conditions
- Block
- Being tested
- Block group
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block groupOther
Also called Patients received thoracolumbar interfascial plane block before operation
Control group
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Visual analog scale
Measured: one time in postoperative period for one year
Secondary outcomes (1)
Opioid consumption
Opioid consumption
Measured: During postoperative period for one yea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start7 Sep 2020
- Primary completion21 Aug 2021
- Study completion7 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548076
- Sponsor's protocol ID
- 20-KAEK-076
- Status last verified
- Mar 2022
- First submitted
- 7 Sep 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tapar H, Demir O, Genc A, Balta MG, Kolukcu V, Karaman T, Dogru S, Karaman S, Suren M. Investigation of the analgesic efficacy of ultrasound-guided thoracolumbar interfacial plane block in vertebral surgery: A prospective randomized clinical study. Saudi Med J. 2022 Oct;43(10):1136-1141. doi: 10.15537/smj.2022.43.10.20220467.
PubMed 36261200
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Analgesic Efficacy of Thoracolumbar Interfascial Plane Block in Vertebral Surgery
- ClinicalTrials.gov ID
- NCT04548076
- Acronym / sponsor ID
- 20-KAEK-076
- Conditions
- Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 7 Nov 2021 (actual)
- First posted
- 14 Sep 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.
To determine the postoperative analgesic efficiency of thoracolumbar interfascial plane block , patients are divided into two groups. Study group received ultrasound-guided thoracolumbar interfascial plane block , where control had none. Visual analog scale and opioid consumption are recorded.
Detailed description
Thoracolumbar interfascial plane block has successfully been demonstrated to provide an efficient analgesia in patients. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of thoracolumbar interfascial plane block in patients with vertebral surgery. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.
In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS>4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS>4 the same dose will be repeated. A patient satisfaction questionnaire (Qr40)will be filled by patients at the postoperative 24th hour.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vertebral surgery patients who will be operated under general anesthesia.
Key inclusion criteria (1 listed)
- Over 18 years of age, Planned to vertebral surgery, An American Society of Anesthesiologists score of 1,2 or 3
Key exclusion criteria (1 listed)
- Severe cardiovascular disease, Psychiatric diseases, Rejected to participation, Those who have chronic pain
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 |
|---|---|---|
| Block groupAlso: Patients received thoracolumbar interfascial plane block before operationControl group | Other | – |
Primary outcome
Visual analog scale
Time frame: one time in postoperative period for one year
Visual analog scale
1 secondary outcome
Opioid consumption
Time frame: During postoperative period for one yea
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 15 Mar 2022.
- Derived from this study: PubMed 36261200Tapar H, Demir O, Genc A, Balta MG, Kolukcu V, Karaman T, Dogru S, Karaman S, Suren M. Investigation of the analgesic efficacy of ultrasound-guided thoracolumbar interfacial plane block in vertebral surgery: A prospective randomized clinical study. Saudi Med J. 2022 Oct;43(10):1136-1141. doi: 10.15537/smj.2022.43.10.20220467.
- 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.
Hakan Tapar principal investigator
Gaziosmanpasa 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 Block, run by Tokat Gaziosmanpasa 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 1 inclusion and 1 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 15 Mar 2022. 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 scale (time frame: one time in postoperative period for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04548076, which also lists 1 linked publication.
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 15 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.