Lumbar Disc HerniationPhase 4NCT04457986
Plane Block vs Intravenous Patient Controlled Analgesia
A Phase 4 study testing Erector spina plane block (ESP) and Modified thoracolumbar interfacial plane block (MTI) in people with Lumbar Disc Herniation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute postoperative pain begins with surgical trauma and decreases with tissue healing. Untreatable postoperative pain is one of the most important problems due to the increase in respiratory, cardiac and thromboembolic complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Erector spina plane block (ESP) and Modified thoracolumbar interfacial plane block (MTI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Oct 2020
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective lumber discectomy or laminectomy
- Adults
- Aged 18-65
- America Society of Anesthesiologists physical status I-III
Who cannot join
- Emergency surgery
- Chronic pain condition
- Allergic to study drugs
- Recurrent surgical cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06110
About this study
Official title: Randomized Controlled Comparison of the Erector Spina Plane Block and Modified Thoracolumbar Interfacial Plane Block and Intravenous Patient Controlled Analgesia in Patients Undergoing Lumbar Disc Surgery
Acute postoperative pain begins with surgical trauma and decreases with tissue healing. Untreatable postoperative pain is one of the most important problems due to the increase in respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely performed, and patients often complain of postoperative pain.
Preventing and managing postoperative pain after lumber disc surgery is very important for anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids, preemptive analgesia methods, intravenous patient controlled analgesia methods and regional anesthesia techniques are used within the multimodal analgesia strategy.
Read more
Regional anesthesia techniques are becoming increasingly widespread due to their efficiency and increased applicability thanks to the use of ultrasonography. Regional anesthesia techniques used in lumber disc surgery include paravertebral block, local anesthetic infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar interfacial plan block in recent years.
The erector spina plane block was first described in 2016, and the thoracolumbar interfacial plane block in 2015, and its modification was developed in 2017. Although they vary depending on the level of application, they offer analgesic activity in a wide range. Although there are publications about the use of these blocks for postoperative analgesia after lumber surgeries, which block is more effective has not been investigated.
This study may contribute to the development of new options for pain management after lumber disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial plane block, which have recently been used for postoperative pain treatment, with limited research, with each other and the standard technique, intravenous patient controlled analgesia, can add new applications to multimodal analgesia methods, increase patient satisfaction and contribute to the early recovery process.
The objective is to compare the erector spina plane block and modified thoracolumbar interfacial plane block in patients undergoing lumber disc surgery with intravenous patient-controlled analgesia in terms of analgesic efficacy.
Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block may decrease the postoperative pain scores, opioid consumption and time to first analgesic requirement compared with intravenous patient controlled analgesia.
Read the detailed description
Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or Intravenous patient controlled analgesia IV-PCA.
Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the preoperative holding area.
All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated with a numeric rating scale at postoperative recovery room admittance, postoperative 1st , second, 4th, 12th and 24th hours both at rest and during movement.
Postoperative tramadol consumption and time to first tramadol demand will be determined.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Erector spina plane block (ESP), Modified thoracolumbar interfacial plane block (MTI), Intravenous patient controlled analgesia (IV-PCA)
- Keywords
- postoperative pain, erector spina plane block, thoracolumbar interfacial plane block, patient controlled analgesia
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane block (ESP)Drug
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Modified thoracolumbar interfacial plane block (MTI)Drug
Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
Intravenous patient controlled analgesia (IV-PCA)Drug
Patient will receive intravenous patient controlled analgesia with tramadol
| Study group | Role | What they receive |
|---|---|---|
| Erector spina plane block (ESP) | Experimental | Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia Receives: Drug: Erector spina plane block (ESP) |
| Modified thoracolumbar interfacial plane block (MTI) | Experimental | Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia Receives: Drug: Modified thoracolumbar interfacial plane block (MTI) |
| Intravenous patient controlled analgesia (IV-PCA) | Active comparator | Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia Receives: Drug: Intravenous patient controlled analgesia (IV-PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: 10 minutes after extubation
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: postoperative 1st hour
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: postoperative 2nd hour
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: postoperative 4th hour
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: postoperative 12th hour
Pain score
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Measured: postoperative 24th hour
Tramadol consumption
Tramadol consumption will be determined from the ambulatory infusion pump (Abott)
Measured: postoperative 24th hour
Time to first analgesia request
Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)
Measured: 10 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- ÜNAL Dr YAZICIOĞLU, Assoc Prof, Principal investigator, DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457986
- Sponsor's protocol ID
- ESP-MTIP-IVPCA
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
PubMed 26149600Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
PubMed 31029989
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Comparison of the Erector Spina Plane Block and Modified Thoracolumbar Interfacial Plane Block and Intravenous Patient Controlled Analgesia in Patients Undergoing Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT04457986
- Acronym / sponsor ID
- ESP-MTIP-IVPCA
- Conditions
- Lumbar Disc Herniation
- Keywords
- postoperative pain, erector spina plane block, thoracolumbar interfacial plane block, patient controlled analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 7 Jul 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.
Acute postoperative pain begins with surgical trauma and decreases with tissue healing. Untreatable postoperative pain is one of the most important problems due to the increase in respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely performed, and patients often complain of postoperative pain.
Preventing and managing postoperative pain after lumber disc surgery is very important for anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids, preemptive analgesia methods, intravenous patient controlled analgesia methods and regional anesthesia techniques are used within the multimodal analgesia strategy.
Regional anesthesia techniques are becoming increasingly widespread due to their efficiency and increased applicability thanks to the use of ultrasonography. Regional anesthesia techniques used in lumber disc surgery include paravertebral block, local anesthetic infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar interfacial plan block in recent years.
The erector spina plane block was first described in 2016, and the thoracolumbar interfacial plane block in 2015, and its modification was developed in 2017. Although they vary depending on the level of application, they offer analgesic activity in a wide range. Although there are publications about the use of these blocks for postoperative analgesia after lumber surgeries, which block is more effective has not been investigated.
This study may contribute to the development of new options for pain management after lumber disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial plane block, which have recently been used for postoperative pain treatment, with limited research, with each other and the standard technique, intravenous patient controlled analgesia, can add new applications to multimodal analgesia methods, increase patient satisfaction and contribute to the early recovery process.
The objective is to compare the erector spina plane block and modified thoracolumbar interfacial plane block in patients undergoing lumber disc surgery with intravenous patient-controlled analgesia in terms of analgesic efficacy.
Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block may decrease the postoperative pain scores, opioid consumption and time to first analgesic requirement compared with intravenous patient controlled analgesia.
Detailed description
Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or Intravenous patient controlled analgesia IV-PCA.
Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the preoperative holding area.
All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated with a numeric rating scale at postoperative recovery room admittance, postoperative 1st , second, 4th, 12th and 24th hours both at rest and during movement.
Postoperative tramadol consumption and time to first tramadol demand will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector spina plane block (ESP) | Experimental | Drug: Erector spina plane block (ESP)Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia |
| Modified thoracolumbar interfacial plane block (MTI) | Experimental | Drug: Modified thoracolumbar interfacial plane block (MTI)Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia |
| Intravenous patient controlled analgesia (IV-PCA) | Active comparator | Drug: Intravenous patient controlled analgesia (IV-PCA)Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective lumber discectomy or laminectomy
- Adults
- Aged 18-65
- America Society of Anesthesiologists physical status I-III
Key exclusion criteria (4 listed)
- Emergency surgery
- Chronic pain condition
- Allergic to study drugs
- Recurrent surgical cases
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 spina plane block (ESP)Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol | Drug | Erector spina plane block (ESP) |
| Modified thoracolumbar interfacial plane block (MTI)Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol | Drug | Modified thoracolumbar interfacial plane block (MTI) |
| Intravenous patient controlled analgesia (IV-PCA)Patient will receive intravenous patient controlled analgesia with tramadol | Drug | Intravenous patient controlled analgesia (IV-PCA) |
Primary outcome
Pain score
Time frame: 10 minutes after extubation
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Time frame: postoperative 1st hour
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Time frame: postoperative 2nd hour
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Time frame: postoperative 4th hour
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Time frame: postoperative 12th hour
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Pain score
Time frame: postoperative 24th hour
Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
Tramadol consumption
Time frame: postoperative 24th hour
Tramadol consumption will be determined from the ambulatory infusion pump (Abott)
Time to first analgesia request
Time frame: 10 minutes after extubation
Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)
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 9 Nov 2020.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 26149600Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
- Results publication: PubMed 31029989Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
- 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.
ÜNAL Dr YAZICIOĞLU, Assoc Prof principal investigator
DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector spina plane block (ESP) and Modified thoracolumbar interfacial plane block (MTI) in people with Lumbar Disc Herniation, run by Diskapi Teaching 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 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 9 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score (time frame: 10 minutes after extubation). The study lists 8 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 NCT04457986, which also lists 3 linked publications.
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 9 Nov 2020.