Postoperative PainNCT04193488
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
A study testing MTP block, ESP block and No Block group in people with Postoperative Pain and Anesthesia, Regional, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in "Gülhane Training and Research Hospital" were planned to be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Anesthesia, Regional, Spinal Stenosis
- What is being tested?
- MTP block, ESP block and No Block group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2019to 15 Jan 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old
- ASA (American Society of Anesthesiologists) score between I-III.
Who cannot join
- ASA (American Society of Anesthesiologists) score >III,
- emergency surgery,
- secondary surgery,
- receiving chronic pain treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Keçiören, 06100
About this study
Official title: Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in "Gülhane Training and Research Hospital" were planned to be included in the study. Patients will be randomized to 30 patients with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K) in addition to patient-controlled analgesia (PCA). Postoperative pain scores, analgesic use, number of PCA button presses, total amount of opioid administered and complications due to opioids will be recorded. The obtained data will be compared statistically.
Read the detailed description
Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in Gulhane Training and Research Hospital were planned to be included in the study. Appropriate patients will be informed about the study and their written consent will be obtained. All patients were scheduled for ASA I-III. Exclusion criteria for patients are as follows: ≤18 or ≥81 years old, body mass index (BMI) ≥30 or ≤18 kg / m2, skin infection where the needle is punctured, allergic drugs to any of the study, pre-existing pain syndromes, pregnancy, severe liver diseases), kidney diseases (serum creatinine greater than 2 mg / dL, oliguria, anuria or hemodialysis) or cardiovascular disorders (functional class of the New York Heart Association greater than III). During the preoperative visit, all patients will be instructed on how to assess their pain using a numerical analogue pain scale (0 = no pain, 10 = maximum pain to be considered) and patient-controlled analgesia (PCA). Patients will be randomized according to a computer-generated random number table, in addition to patient-controlled analgesia (PCA) with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K). Nerve blocks will be made at the end of the operation after the surgical site is sutured and intact before the dressing is done. The linear ultrasound probe will be applied in the prone position bilaterally in the region of the transverse process corresponding to the center of the incision line by the same three experienced senior doctors with ultrasound guidance covered with sterile probe sheath. In the ESPB group, a high-frequency 15 6 MHz (Megahertz) linear ultrasound probe will be placed vertically about 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transverse projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied 3 cm later than the incision line. In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral cavity. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.
No regional plan block will be applied to the control group. All groups will receive analgesia in the postoperative period using patient-controlled analgesia (PCA), and the pain will be evaluated three days postoperatively using a numerical grading scale (NRS) ranging from 0 (painless) to 10 (worst imaginable pain). The number of PCA button presses, the total amount of opioids applied, and complications associated with opioids will be recorded. The obtained data will be compared statistically
- Conditions
- Postoperative Pain, Anesthesia, Regional, Spinal Stenosis
- Being tested
- MTP block, ESP block, No Block group
- Keywords
- spinal surgery, Erector spina plan block, Mid-transverse process to pleura block, post-operative analgesia
- Medical subject headings
- Pain, Postoperative, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP blockBehavioural
In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasagital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.
ESP blockBehavioural
In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line.
No Block groupBehavioural
No regional plan block will be applied to the control group. Conventional analgesic methods were applied.
| Study group | Role | What they receive |
|---|---|---|
| MTP block (Group MTP) | Active comparator | In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line. Receives: Behavioral: MTP block |
| ESP block (Group ESP) | Active comparator | In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line. Receives: Behavioral: ESP block |
| no block (Group C) | Active comparator | No regional plan block will be applied to the control group. Conventional analgesic methods were applied. Receives: Behavioral: No Block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale (NRS)
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) was assessed using three days after surgery
Measured: three days postoperatively
use of patient control analgesia
The number of PCA button presses, the total amount of opioids applied
Measured: three days postoperatively
complications related to opioids
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration, Drowsiness or difficulty staying awake, Feeling of light dizziness, Feeling of dizziness, Feelings of general fatigue or weakness, Dry mouth, Headache
Measured: three days postoperatively
Additional analgesic use
Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered to patients with an NRS score> 3 and the amount of use will be recorded.analgesics
Measured: three days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start23 Oct 2019
- Primary completion1 Jan 2020
- Study completion15 Jan 2020
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.
- 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
- Patients will be randomized to 30 patients with MTP block (Group MTP) and 30 patients with ESP block (Group ESP) and 30 patients with no block (Group K) in addition to patient-controlled analgesia (PCA).
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
- Investigators
- Mehmet B EŞKİN, Study director, Gulhane Training and Research HospitalAyşegül Ceylan, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193488
- Sponsor's protocol ID
- 19/342
- Status last verified
- Feb 2020
- First submitted
- 4 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
- ClinicalTrials.gov ID
- NCT04193488
- Acronym / sponsor ID
- 19/342
- Conditions
- Postoperative Pain, Anesthesia, Regional, Spinal Stenosis
- Keywords
- spinal surgery, Erector spina plan block, Mid-transverse process to pleura block, post-operative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 10 Dec 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.
Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in "Gülhane Training and Research Hospital" were planned to be included in the study. Patients will be randomized to 30 patients with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K) in addition to patient-controlled analgesia (PCA). Postoperative pain scores, analgesic use, number of PCA button presses, total amount of opioid administered and complications due to opioids will be recorded. The obtained data will be compared statistically.
Detailed description
Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in Gulhane Training and Research Hospital were planned to be included in the study. Appropriate patients will be informed about the study and their written consent will be obtained. All patients were scheduled for ASA I-III. Exclusion criteria for patients are as follows: ≤18 or ≥81 years old, body mass index (BMI) ≥30 or ≤18 kg / m2, skin infection where the needle is punctured, allergic drugs to any of the study, pre-existing pain syndromes, pregnancy, severe liver diseases), kidney diseases (serum creatinine greater than 2 mg / dL, oliguria, anuria or hemodialysis) or cardiovascular disorders (functional class of the New York Heart Association greater than III). During the preoperative visit, all patients will be instructed on how to assess their pain using a numerical analogue pain scale (0 = no pain, 10 = maximum pain to be considered) and patient-controlled analgesia (PCA). Patients will be randomized according to a computer-generated random number table, in addition to patient-controlled analgesia (PCA) with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K). Nerve blocks will be made at the end of the operation after the surgical site is sutured and intact before the dressing is done. The linear ultrasound probe will be applied in the prone position bilaterally in the region of the transverse process corresponding to the center of the incision line by the same three experienced senior doctors with ultrasound guidance covered with sterile probe sheath. In the ESPB group, a high-frequency 15 6 MHz (Megahertz) linear ultrasound probe will be placed vertically about 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transverse projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied 3 cm later than the incision line. In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral cavity. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.
No regional plan block will be applied to the control group. All groups will receive analgesia in the postoperative period using patient-controlled analgesia (PCA), and the pain will be evaluated three days postoperatively using a numerical grading scale (NRS) ranging from 0 (painless) to 10 (worst imaginable pain). The number of PCA button presses, the total amount of opioids applied, and complications associated with opioids will be recorded. The obtained data will be compared statistically
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomized to 30 patients with MTP block (Group MTP) and 30 patients with ESP block (Group ESP) and 30 patients with no block (Group K) in addition to patient-controlled analgesia (PCA).
| Arm | Type | Receives |
|---|---|---|
| MTP block (Group MTP) | Active comparator | Behavioral: MTP blockIn the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line. |
| ESP block (Group ESP) | Active comparator | Behavioral: ESP blockIn the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line. |
| no block (Group C) | Active comparator | Behavioral: No Block groupNo regional plan block will be applied to the control group. Conventional analgesic methods were applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years old
- ASA (American Society of Anesthesiologists) score between I-III.
Key exclusion criteria (4 listed)
- ASA (American Society of Anesthesiologists) score >III,
- emergency surgery,
- secondary surgery,
- receiving chronic pain treatment
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 |
|---|---|---|
| MTP blockIn the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasagital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line. | Behavioural | MTP block (Group MTP) |
| ESP blockIn the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line. | Behavioural | ESP block (Group ESP) |
| No Block groupNo regional plan block will be applied to the control group. Conventional analgesic methods were applied. | Behavioural | no block (Group C) |
Primary outcome
numeric rating scale (NRS)
Time frame: three days postoperatively
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) was assessed using three days after surgery
use of patient control analgesia
Time frame: three days postoperatively
The number of PCA button presses, the total amount of opioids applied
complications related to opioids
Time frame: three days postoperatively
Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration, Drowsiness or difficulty staying awake, Feeling of light dizziness, Feeling of dizziness, Feelings of general fatigue or weakness, Dry mouth, Headache
Additional analgesic use
Time frame: three days postoperatively
Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered to patients with an NRS score> 3 and the amount of use will be recorded.analgesics
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 5 Feb 2020.
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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.
Mehmet B EŞKİN study director
Gulhane Training and Research Hospital
Ayşegül Ceylan principal investigator
Gulhane 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 MTP block, ESP block and No Block group in people with Postoperative Pain and Anesthesia, Regional, run by Gulhane School of Medicine 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 2 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 5 Feb 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?
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?
numeric rating scale (NRS) (time frame: three days postoperatively). The study lists 4 primary outcomes in all. 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 5 Feb 2020.