Low Back PainNCT04028154
Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
A study testing Erector Spinae Plane (ESP) Block and Thoracolumbar interfacial plane (TLIP) Block in people with Low Back Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Erector Spinae Plane (ESP) Block and Thoracolumbar interfacial plane (TLIP) Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 68 patients
- ASA I-III,
- Aged 18-75 years
- underwent lumbar spine surgery under elective conditions
Who cannot join
- Presence of contraindications to LA agents used in this study
- Use of chronic opioids,
- Psychiatric disorders.
- The presence of infection at the injection area.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100
sinem sari, 090 4441256-2108, sarisinem@yahoo.com
İsmet Topçu
About this study
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
Read the detailed description
Plan blocks are used as a good and safe option for multimodal analgesia techniques in postoperative pain control in spinal surgery.
The ESP block was first described in 2016 for the treatment of thoracic neuropathic pain.
In the following process; ESP block has been reported to provide effective postoperative analgesia in thoracic and breast surgery, bariatric surgery and upper abdominal surgery.
Finally, ESP block has been reported to provide effective postoperative analgesia in veretebra surgeries.
The mechanism of ESP analgesic action has been demonstrated in cadaver studies where injected local anesthetics are caused by diffusion of the spinal nerves into the ventral and dorsal ramycin by spreading in the cranial and caudal directions.
ESP block relieves incisional pain by creating an effective block in a wide area of the posterior, lateral and anterior thoracic and lumbar walls.
In addition, ESP block prevents visceral autonomic pain and provides good postoperative analgesia.
The thoracolumbar interfacial plan block (TLIP) is the other para-spinal plan block.
In this ultrasound guided block, local anesthetic targets the dorsal branches of the thoracolumbar nerves by spreading between the facies of the multifidus and longissimus muscles at the 3rd lumbar spine.
In this way, it has been reported to provide effective analgesia in spinal surgeries.
Routine ultrasonography guided ESP block or TLIP blog was planned randomly. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol intravenous paracetamol was 1 g and tramadol was 1 mg / kg. Paracetamol and tramadol infusions are then administered every eight hours.
Postoperative analgesia protocol: At the end of the operation, pain levels will be recorded by the Numeric Rating Scale (NRS) system at 30 minutes, 1.6, 12, and 24 hours after the first admission to the recovery room.
Tramadol PCA and paracetamol were administered to the patient every eight hours.
During the follow-up of the patient, it is planned to continue NRS follow-up. In this period, intramuscular 75 mg diclofenac sodium will be administered if NRS is 4 or above.The amount of analgesia consumption, recovery analgesia needs and times will be noted in detail.
When the patient is mobilized and discharged will be recorded.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
- Conditions
- Low Back Pain
- Being tested
- Erector Spinae Plane (ESP) Block, Thoracolumbar interfacial plane (TLIP) Block
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Thoracolumbar interfacial plane (TLIP) BlockProcedure or surgery
TLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Experimental | Not described Receives: Procedure: Erector Spinae Plane (ESP) Block |
| TLIP Block | Active comparator | Not described Receives: Procedure: Thoracolumbar interfacial plane (TLIP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS(numerical rating scala)
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
Measured: [Time Frame: 24 hours]
pruritus
each criterion is reported as present or absent each criterion is reported as present or absent
Measured: [Time Frame: 24 hours]
mobilized
each criterion is reported as when the patient is mobilized
Measured: [Time Frame: 7 days]
nausea and vomiting
each criterion is reported as present or absent each criterion is reported as present or absent
Measured: [Time Frame: 24 hours]
use of antiemetics
each criterion is reported as present or absent each criterion is reported as present or absent
Measured: [Time Frame: 24 hours]
discharged
each criterion is reported as when the patient is discharged
Measured: [Time Frame: 7 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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 Low Back PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
- Investigators
- Sinem Sarı, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028154
- Sponsor's protocol ID
- 2020/06
- Status last verified
- Sep 2020
- First submitted
- 16 Jul 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
PubMed 30758122
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
- ClinicalTrials.gov ID
- NCT04028154
- Acronym / sponsor ID
- 2020/06
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 22 Jul 2019 (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.
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
Detailed description
Plan blocks are used as a good and safe option for multimodal analgesia techniques in postoperative pain control in spinal surgery.
The ESP block was first described in 2016 for the treatment of thoracic neuropathic pain.
In the following process; ESP block has been reported to provide effective postoperative analgesia in thoracic and breast surgery, bariatric surgery and upper abdominal surgery.
Finally, ESP block has been reported to provide effective postoperative analgesia in veretebra surgeries.
The mechanism of ESP analgesic action has been demonstrated in cadaver studies where injected local anesthetics are caused by diffusion of the spinal nerves into the ventral and dorsal ramycin by spreading in the cranial and caudal directions.
ESP block relieves incisional pain by creating an effective block in a wide area of the posterior, lateral and anterior thoracic and lumbar walls.
In addition, ESP block prevents visceral autonomic pain and provides good postoperative analgesia.
The thoracolumbar interfacial plan block (TLIP) is the other para-spinal plan block.
In this ultrasound guided block, local anesthetic targets the dorsal branches of the thoracolumbar nerves by spreading between the facies of the multifidus and longissimus muscles at the 3rd lumbar spine.
In this way, it has been reported to provide effective analgesia in spinal surgeries.
Routine ultrasonography guided ESP block or TLIP blog was planned randomly. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol intravenous paracetamol was 1 g and tramadol was 1 mg / kg. Paracetamol and tramadol infusions are then administered every eight hours.
Postoperative analgesia protocol: At the end of the operation, pain levels will be recorded by the Numeric Rating Scale (NRS) system at 30 minutes, 1.6, 12, and 24 hours after the first admission to the recovery room.
Tramadol PCA and paracetamol were administered to the patient every eight hours.
During the follow-up of the patient, it is planned to continue NRS follow-up. In this period, intramuscular 75 mg diclofenac sodium will be administered if NRS is 4 or above.The amount of analgesia consumption, recovery analgesia needs and times will be noted in detail.
When the patient is mobilized and discharged will be recorded.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Experimental | Procedure: Erector Spinae Plane (ESP) Block |
| TLIP Block | Active comparator | Procedure: Thoracolumbar interfacial plane (TLIP) Block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 68 patients
- ASA I-III,
- Aged 18-75 years
- underwent lumbar spine surgery under elective conditions
Key exclusion criteria (4 listed)
- Presence of contraindications to LA agents used in this study
- Use of chronic opioids,
- Psychiatric disorders.
- The presence of infection at the injection area.
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 Plane (ESP) BlockESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline. | Procedure or surgery | ESP Block |
| Thoracolumbar interfacial plane (TLIP) BlockTLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline. | Procedure or surgery | TLIP Block |
Primary outcome
NRS(numerical rating scala)
Time frame: [Time Frame: 24 hours]
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
pruritus
Time frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
mobilized
Time frame: [Time Frame: 7 days]
each criterion is reported as when the patient is mobilized
nausea and vomiting
Time frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
use of antiemetics
Time frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
discharged
Time frame: [Time Frame: 7 days]
each criterion is reported as when the patient is discharged
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 30758122Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
- 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.
Sinem Sarı principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane (ESP) Block and Thoracolumbar interfacial plane (TLIP) Block in people with Low Back Pain, run by Aydin Adnan Menderes 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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sinem sarı (905075396313, sarısinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS(numerical rating scala) (time frame: [Time Frame: 24 hours]). The study lists 6 primary outcomes in all. 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 NCT04028154, 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 23 Sep 2020.