Postoperative PainTALIPESNCT03931343
Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery
A study testing Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance and Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Bezmialem Vakif University.
Trial summary
Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Opioid Use
- What is being tested?
- Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance and Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Apr 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-75 years
- ASA 1-2-3
- Patients scheduled for elective surgery
Who cannot join
- Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
- Allergy to drugs
- Major cardiac disease
- Renal failure
- Psychiatric disease
- Patients who refuse to participate in the study
- Chronic back and lower back pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.
- Being tested
- Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance, Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
- Keywords
- Thoracolumbar interfascial block, Erector spinae plane block
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidanceProcedure or surgery
Also called Thoracolumbar interfascial plane block
Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidanceProcedure or surgery
Also called Erector spinae plane block
Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar interfascial plane block | Experimental | Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance Receives: Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance |
| Erectro spinae plane block | Active comparator | Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance Receives: Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.
Measured: 48 hour
Secondary outcomes (5)
Pain intensity score at rest
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
Measured: 48 hour
Pain intensity score at movement
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
Measured: 48 hour
Time to first rescue analgesia
If VAS is greater than 3, 25 mg of meperidine will be administered.
Measured: 48 hour
Postoperative nausea and vomiting
Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)
Measured: 48 hour
Patient satisfaction score
Will be scored between 1-5 (1- very bad 5-very good).
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Yeşiltaş, Bezmialem Vakif University
- Investigators
- Serdar Yeşiltaş, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931343
- Sponsor's protocol ID
- S002
- Acronym
- TALIPES
- Status last verified
- Oct 2020
- First submitted
- 26 Apr 2019
- Last updated
- 8 Oct 2020
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
- ClinicalTrials.gov ID
- NCT03931343
- Acronym / sponsor ID
- TALIPES / S002
- Keywords
- Thoracolumbar interfascial block, Erector spinae plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Apr 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.
Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar interfascial plane block | Experimental | Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidanceBilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance |
| Erectro spinae plane block | Active comparator | Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidanceBilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-75 years
- ASA 1-2-3
- Patients scheduled for elective surgery
Key exclusion criteria (7 listed)
- Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
- Allergy to drugs
- Major cardiac disease
- Renal failure
- Psychiatric disease
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 |
|---|---|---|
| Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidanceAlso: Thoracolumbar interfascial plane blockThoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance | Procedure or surgery | Thoracolumbar interfascial plane block |
| Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidanceAlso: Erector spinae plane blockErector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance | Procedure or surgery | Erectro spinae plane block |
Primary outcome
Total morphine consumption
Time frame: 48 hour
The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.
5 secondary outcomes
Pain intensity score at rest
Time frame: 48 hour
Pain intensity score at movement
Time frame: 48 hour
Time to first rescue analgesia
Time frame: 48 hour
Postoperative nausea and vomiting
Time frame: 48 hour
Patient satisfaction score
Time frame: 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Serdar Yeşiltaş principal investigator
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance and Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Bezmialem Vakif University.
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 3 inclusion and 7 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Serdar Yeşiltaş (+905423632630, syesiltas@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 48 hour). 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.