Comparison of Erector Spinae Plane (ESP) Block and Thoracolumbar Interfascial Plane(TLIP) Block for the Management of Postoperative Pain in Spinal Surgery

September 21, 2020 updated by: SINEM SARI, Aydin Adnan Menderes University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Aydın, Turkey, 09100
        • Recruiting
        • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
        • Contact:
        • Sub-Investigator:
          • İsmet Topçu
        • Sub-Investigator:
          • Varlik Erel
        • Sub-Investigator:
          • Berkay Tan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESP Block
Procedure: Erector Spinae Plane (ESP) Block
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Active Comparator: TLIP Block
Procedure: Thoracolumbar interfacial plane (TLIP) Block
TLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NRS(numerical rating scala)
Time Frame: [Time Frame: 24 hours]
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: 24 hours]
pruritus
Time Frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
[Time Frame: 24 hours]
mobilized
Time Frame: [Time Frame: 7 days]
each criterion is reported as when the patient is mobilized
[Time Frame: 7 days]
nausea and vomiting
Time Frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
[Time Frame: 24 hours]
use of antiemetics
Time Frame: [Time Frame: 24 hours]
each criterion is reported as present or absent each criterion is reported as present or absent
[Time Frame: 24 hours]
discharged
Time Frame: [Time Frame: 7 days]
each criterion is reported as when the patient is discharged
[Time Frame: 7 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sinem Sarı, Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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