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Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery

Primary Purpose

Postoperative Pain, Anesthesia, Regional, Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MTP block
ESP block
No Block group
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring spinal surgery, Erector spina plan block, Mid-transverse process to pleura block, post-operative analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-80 years old
  • ASA (American Society of Anesthesiologists) score between I-III.

Exclusion Criteria:

  • ASA (American Society of Anesthesiologists) score >III,
  • emergency surgery,
  • secondary surgery,
  • receiving chronic pain treatment

Sites / Locations

  • Gulhane Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

MTP block (Group MTP)

ESP block (Group ESP)

no block (Group C)

Arm Description

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.

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.

No regional plan block will be applied to the control group. Conventional analgesic methods were applied.

Outcomes

Primary Outcome Measures

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
use of patient control analgesia
The number of PCA button presses, the total amount of opioids applied
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
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

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
February 4, 2020
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04193488
Brief Title
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
Official Title
Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Regional, Spinal Stenosis
Keywords
spinal surgery, Erector spina plan block, Mid-transverse process to pleura block, post-operative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTP block (Group MTP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ESP block (Group ESP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
no block (Group C)
Arm Type
Active Comparator
Arm Description
No regional plan block will be applied to the control group. Conventional analgesic methods were applied.
Intervention Type
Behavioral
Intervention Name(s)
MTP block
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ESP block
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Block group
Intervention Description
No regional plan block will be applied to the control group. Conventional analgesic methods were applied.
Primary Outcome Measure Information:
Title
numeric rating scale (NRS)
Description
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) was assessed using three days after surgery
Time Frame
three days postoperatively
Title
use of patient control analgesia
Description
The number of PCA button presses, the total amount of opioids applied
Time Frame
three days postoperatively
Title
complications related to opioids
Description
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
Time Frame
three days postoperatively
Title
Additional analgesic use
Description
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
Time Frame
three days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-80 years old ASA (American Society of Anesthesiologists) score between I-III. Exclusion Criteria: ASA (American Society of Anesthesiologists) score >III, emergency surgery, secondary surgery, receiving chronic pain treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet B EŞKİN
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayşegül Ceylan
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery

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