Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane (ESP) Block
Thoracolumbar interfacial plane (TLIP) Block
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 68 patients
- ASA I-III,
- Aged 18-75 years
- underwent lumbar spine surgery under elective conditions
Exclusion Criteria:
- Presence of contraindications to LA agents used in this study
- Use of chronic opioids,
- Psychiatric disorders.
- The presence of infection at the injection area.
Sites / Locations
- Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESP Block
TLIP Block
Arm Description
Outcomes
Primary Outcome Measures
NRS(numerical rating scala)
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
pruritus
each criterion is reported as present or absent each criterion is reported as present or absent
mobilized
each criterion is reported as when the patient is mobilized
nausea and vomiting
each criterion is reported as present or absent each criterion is reported as present or absent
use of antiemetics
each criterion is reported as present or absent each criterion is reported as present or absent
discharged
each criterion is reported as when the patient is discharged
Secondary Outcome Measures
Full Information
NCT ID
NCT04028154
First Posted
July 16, 2019
Last Updated
September 21, 2020
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT04028154
Brief Title
Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
Official Title
Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
Detailed Description
Plan blocks are used as a good and safe option for multimodal analgesia techniques in postoperative pain control in spinal surgery.
The ESP block was first described in 2016 for the treatment of thoracic neuropathic pain.
In the following process; ESP block has been reported to provide effective postoperative analgesia in thoracic and breast surgery, bariatric surgery and upper abdominal surgery.
Finally, ESP block has been reported to provide effective postoperative analgesia in veretebra surgeries.
The mechanism of ESP analgesic action has been demonstrated in cadaver studies where injected local anesthetics are caused by diffusion of the spinal nerves into the ventral and dorsal ramycin by spreading in the cranial and caudal directions.
ESP block relieves incisional pain by creating an effective block in a wide area of the posterior, lateral and anterior thoracic and lumbar walls.
In addition, ESP block prevents visceral autonomic pain and provides good postoperative analgesia.
The thoracolumbar interfacial plan block (TLIP) is the other para-spinal plan block.
In this ultrasound guided block, local anesthetic targets the dorsal branches of the thoracolumbar nerves by spreading between the facies of the multifidus and longissimus muscles at the 3rd lumbar spine.
In this way, it has been reported to provide effective analgesia in spinal surgeries.
Routine ultrasonography guided ESP block or TLIP blog was planned randomly. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol intravenous paracetamol was 1 g and tramadol was 1 mg / kg. Paracetamol and tramadol infusions are then administered every eight hours.
Postoperative analgesia protocol: At the end of the operation, pain levels will be recorded by the Numeric Rating Scale (NRS) system at 30 minutes, 1.6, 12, and 24 hours after the first admission to the recovery room.
Tramadol PCA and paracetamol were administered to the patient every eight hours.
During the follow-up of the patient, it is planned to continue NRS follow-up. In this period, intramuscular 75 mg diclofenac sodium will be administered if NRS is 4 or above.The amount of analgesia consumption, recovery analgesia needs and times will be noted in detail.
When the patient is mobilized and discharged will be recorded.
The aim of this study was to compare the efficacy of erector spina plan(ESP) block and thoraco lumbar interfacial(TLIP) block on postoperative pain in patients with spinal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP Block
Arm Type
Experimental
Arm Title
TLIP Block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane (ESP) Block
Intervention Description
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Intervention Type
Procedure
Intervention Name(s)
Thoracolumbar interfacial plane (TLIP) Block
Intervention Description
TLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Primary Outcome Measure Information:
Title
NRS(numerical rating scala)
Description
Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours
Time Frame
[Time Frame: 24 hours]
Title
pruritus
Description
each criterion is reported as present or absent each criterion is reported as present or absent
Time Frame
[Time Frame: 24 hours]
Title
mobilized
Description
each criterion is reported as when the patient is mobilized
Time Frame
[Time Frame: 7 days]
Title
nausea and vomiting
Description
each criterion is reported as present or absent each criterion is reported as present or absent
Time Frame
[Time Frame: 24 hours]
Title
use of antiemetics
Description
each criterion is reported as present or absent each criterion is reported as present or absent
Time Frame
[Time Frame: 24 hours]
Title
discharged
Description
each criterion is reported as when the patient is discharged
Time Frame
[Time Frame: 7 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
68 patients
ASA I-III,
Aged 18-75 years
underwent lumbar spine surgery under elective conditions
Exclusion Criteria:
Presence of contraindications to LA agents used in this study
Use of chronic opioids,
Psychiatric disorders.
The presence of infection at the injection area.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sinem sarı
Phone
905075396313
Email
sarısinem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Sarı
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
City
Aydın
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sinem sari
Phone
090 4441256-2108
Email
sarisinem@yahoo.com
First Name & Middle Initial & Last Name & Degree
İsmet Topçu
First Name & Middle Initial & Last Name & Degree
Varlik Erel
First Name & Middle Initial & Last Name & Degree
Berkay Tan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30758122
Citation
Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
Results Reference
background
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Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery
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