Spinal SurgeryTLIPvsESPNCT05023850
Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block
A study testing TLIPB and ESPB in people with Spinal Surgery and Quality of Recovery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Major spinal surgery causes greater pain in the postoperative 24 hours. Patients with severe pain may have prolonged hospital stays and delay in mobilization. In addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery, Quality of Recovery, Postoperative Analgesia
- What is being tested?
- TLIPB and ESPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 23 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥ 18 years old,
- Undergoing posterior lumbar spinal one to three levels fusion surgery
- Having signed a written informed consent form,
- ASAI-III
Who cannot join
- Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,…)
- Contraindication to nonsteroidal anti-inflammatory drugs,
- Patient who has already had a spinal surgery,
- Patient with chronic pain syndrome (use > 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
- A mental or linguistic inability to understand the study,
- Pregnant or or breastfeeding women,
- Patient who can not communicate in Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block for Thoracolumbar Decompressive Surgery: a Randomized Clinical Trial
Major spinal surgery causes greater pain in the postoperative 24 hours. Patients with severe pain may have prolonged hospital stays and delay in mobilization. In addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing major spinal surgery.
Recently, ultrasound-guided interfascial plane blocks such as thoracolumbar interfascial plane block (TLIPB)and the erector spinae plane block (ESPB) have been described in spinal surgery. Both blocks clinically seem to be safe and easily performed. The aims of this study are to compare the quality of recovery scores, overall morbidity and postoperative analgesia after major spinal surgery in patients receiving either TLIPB or ESPB.
Read the detailed description
Thoracolumbar interfascial plane block (TLIPB)and erector spinae plane block (ESPB) and have been shown to provide effective analgesia after spinal surgery. ESPB targets ventral and dorsal rami of the spinal nerve and also spreads over the paravertebral and epidural space. However, TLIPB targets only dorsal rami of the spinal nerve and spare ventral rami which may provide early ambulation. In addition, depositing local anesthetic in the fascial planes may prevent intraoperative washout. It may translate to an increase in the quality of analgesia. On the other hand, pain is an incomplete measure of postoperative recovery. No study to date has compared these two blocks in terms of the quality of recovery after major spinal surgery. This study will test the hypothesis that patients receiving TLIPB have higher QoR-40 scores in comparison with patients receiving ESPB.
- Being tested
- TLIPB, ESPB
- Keywords
- Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Thoracolumbar Decompressive Surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIPBProcedure or surgery
Also called Global Quality of Recovery-40 score, Standard Pain Follow up and Monitorization
Patients will receive TLIPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
ESPBProcedure or surgery
Also called Global Quality of Recovery-40 score, Standard Pain Followup and Monitorization
Patients will receive ESPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between erector spinae muscle and transverse process of a vertebra.
| Study group | Role | What they receive |
|---|---|---|
| Group TLIP | Active comparator | Patients will receive a Thoracolumbar Plane Block (TLIPB) under ultrasound guidance while under general anesthesia.
Intervention: Patients will receive a TLIPB with 20mls 0.25% Bupivicaine bilaterally. Receives: Procedure: TLIPB |
| Group ESP | Experimental | Patients will receive an Erector Spinae Plane Block (ESPB) under ultrasound guidance while under general anesthesia.
Intervention: Procedure: Patients will receive an ESPB with 20 ml 0.25% Bupivacaine bilaterally. Receives: Procedure: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR-40) Score
QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. I rate each item on a scale of 1-5, providing a minimum score of 40 and maximum of 200.QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.Global QoR-40 scores range from 40 to 200 representing, respectively, very poor to outstanding quality of recovery. QoR-40 score will be recorded on the morning of operation and at the postoperative 24th hour.
Measured: Postoperative 24th hour
Secondary outcomes (6)
Area under the Numeric Rating Scale pain score versus time
11-point Numerical Rating Scale pain score is measured from '0' (means no pain) to '10' (means worst pain imaginable) both at rest and during sitting.
Measured: Postoperative 24 hours
Numeric Rating Scale pain score
Pain scores using a Numeric Rating Scale (NRS) ranging from 0 to 10 (0= no pain; 10= worst imaginable pain). These scores will be recorded before surgery, in PACU and 6th, 12th and 24th at the postoperative period, both at rest and during sitting.
and 24th hour pain imaginable).
Measured: Postoperative 24 hours
Documentation of adverse events
Nausea and vomiting
Measured: Postoperative 24 hours
Postoperative opioid consumption in the first 24 hours
Subjects will be extubated, taken to the postanesthesia care unit (PACU) and will be received by a nurse blinded to randomization. A standard PACU opioid algorithm will be used which involved:
- intravenous fentanyl 25 µg for Numeric Rating Scale (NRS) pain scores of either 4 or 5
- intravenous fentanyl 50 µg for NRS of 6 or greater. On discharge to the ward, subjects will be provided immediate-release oral oxycodone 5 mg every 4 hours as needed for NRS of 4-6; and 10 mg every 4 hours as needed for NRS of 7-10.
All opioid doses will be converted to morphine equivalents.
Measured: Postoperative 24 hours
Time for administration of first opioid analgesia
Time to administration of first opioid analgesia in the postanesthesia care unit
Measured: Postoperative 24 hours
Postoperative complications
Postoperative complications will be identified by visiting patients every day or alternate day during their in-hospital course, supplemented by patients' medical records review by assessors masked to group allocation, using our hospital's electronic patient record database. We will use the Claviene Dindo Classification system from which CCI is derived. We defined a postoperative complication as any deviation from the ideal postoperative course, not inherent in the procedure itself and does not constitute a failure to cure. CCI scores will be calculated using the online CCI calculator.
Measured: Postoperative thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start10 Sep 2021
- Primary completion23 May 2022
- Study completion23 May 2022
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 Spinal SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Basaran, MD, DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023850
- Sponsor's protocol ID
- 05-2021/13
- Acronym
- TLIPvsESP
- Status last verified
- Sep 2021
- First submitted
- 19 Aug 2021
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilge A, Basaran B. Postoperative quality of recovery with erector spinae plane block or thoracolumbar interfascial plane block after major spinal surgery: a randomized controlled trial. Eur Spine J. 2024 Jan;33(1):68-76. doi: 10.1007/s00586-023-07998-6. Epub 2023 Oct 27.
PubMed 37889327
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block for Thoracolumbar Decompressive Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05023850
- Acronym / sponsor ID
- TLIPvsESP / 05-2021/13
- Keywords
- Thoracolumbar Interfascial Plane Block, Erector Spinae Plane Block, Thoracolumbar Decompressive Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 27 Aug 2021 (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.
Major spinal surgery causes greater pain in the postoperative 24 hours. Patients with severe pain may have prolonged hospital stays and delay in mobilization. In addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing major spinal surgery.
Recently, ultrasound-guided interfascial plane blocks such as thoracolumbar interfascial plane block (TLIPB)and the erector spinae plane block (ESPB) have been described in spinal surgery. Both blocks clinically seem to be safe and easily performed. The aims of this study are to compare the quality of recovery scores, overall morbidity and postoperative analgesia after major spinal surgery in patients receiving either TLIPB or ESPB.
Detailed description
Thoracolumbar interfascial plane block (TLIPB)and erector spinae plane block (ESPB) and have been shown to provide effective analgesia after spinal surgery. ESPB targets ventral and dorsal rami of the spinal nerve and also spreads over the paravertebral and epidural space. However, TLIPB targets only dorsal rami of the spinal nerve and spare ventral rami which may provide early ambulation. In addition, depositing local anesthetic in the fascial planes may prevent intraoperative washout. It may translate to an increase in the quality of analgesia. On the other hand, pain is an incomplete measure of postoperative recovery. No study to date has compared these two blocks in terms of the quality of recovery after major spinal surgery. This study will test the hypothesis that patients receiving TLIPB have higher QoR-40 scores in comparison with patients receiving ESPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial one group receives Thoracolumbar Interfascial Plane Block the other receives Erector Spinae Plane Block
| Arm | Type | Receives |
|---|---|---|
| Group TLIP | Active comparator | Procedure: TLIPBPatients will receive a Thoracolumbar Plane Block (TLIPB) under ultrasound guidance while under general anesthesia. Intervention: Patients will receive a TLIPB with 20mls 0.25% Bupivicaine bilaterally. |
| Group ESP | Experimental | Procedure: ESPBPatients will receive an Erector Spinae Plane Block (ESPB) under ultrasound guidance while under general anesthesia. Intervention: Procedure: Patients will receive an ESPB with 20 ml 0.25% Bupivacaine bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -≥ 18 years old,
- Undergoing posterior lumbar spinal one to three levels fusion surgery
- Having signed a written informed consent form,
- ASAI-III
Key exclusion criteria (7 listed)
- Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,…)
- Contraindication to nonsteroidal anti-inflammatory drugs,
- Patient who has already had a spinal surgery,
- Patient with chronic pain syndrome (use > 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
- A mental or linguistic inability to understand the study,
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 |
|---|---|---|
| TLIPBAlso: Global Quality of Recovery-40 score, Standard Pain Follow up and MonitorizationPatients will receive TLIPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles. | Procedure or surgery | Group TLIP |
| ESPBAlso: Global Quality of Recovery-40 score, Standard Pain Followup and MonitorizationPatients will receive ESPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between erector spinae muscle and transverse process of a vertebra. | Procedure or surgery | Group ESP |
Primary outcome
Quality of Recovery (QoR-40) Score
Time frame: Postoperative 24th hour
QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. I rate each item on a scale of 1-5, providing a minimum score of 40 and maximum of 200.QoR-40, a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.Global QoR-40 scores range from 40 to 200 representing, respectively, very poor to outstanding quality of recovery. QoR-40 score will be recorded on the morning of operation and at the postoperative 24th hour.
6 secondary outcomes
Area under the Numeric Rating Scale pain score versus time
Time frame: Postoperative 24 hours
Numeric Rating Scale pain score
Time frame: Postoperative 24 hours
Documentation of adverse events
Time frame: Postoperative 24 hours
Postoperative opioid consumption in the first 24 hours
Time frame: Postoperative 24 hours
Time for administration of first opioid analgesia
Time frame: Postoperative 24 hours
Postoperative complications
Time frame: Postoperative thirty days
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 24 May 2022.
- Derived from this study: PubMed 37889327Bilge A, Basaran B. Postoperative quality of recovery with erector spinae plane block or thoracolumbar interfascial plane block after major spinal surgery: a randomized controlled trial. Eur Spine J. 2024 Jan;33(1):68-76. doi: 10.1007/s00586-023-07998-6. Epub 2023 Oct 27.
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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.
Betul Basaran, MD, DESA study director
Karaman 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?
A study testing TLIPB and ESPB in people with Spinal Surgery and Quality of Recovery, run by Karaman 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 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: finished, as of the sponsor's last update on 24 May 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?
Quality of Recovery (QoR-40) Score (time frame: Postoperative 24th hour). 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 NCT05023850, 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 24 May 2022.