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

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: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane (ESP) Block; Procedure: Thoracolumbar interfacial plane (TLIP) Block

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sinem sarı; Phone Number: 905075396313; Email: sarısinem@yahoo.com

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Recruiting
    • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
    • Contact: sinem sari; Phone Number: 090 4441256-2108; Email: sarisinem@yahoo.com
    • Sub-Investigator: İsmet Topçu
    • Sub-Investigator: Varlik Erel
    • Sub-Investigator: Berkay Tan

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	[Time Frame: 24 hours]
pruritus	each criterion is reported as present or absent each criterion is reported as present or absent	[Time Frame: 24 hours]
mobilized	each criterion is reported as when the patient is mobilized	[Time Frame: 7 days]
nausea and vomiting	each criterion is reported as present or absent each criterion is reported as present or absent	[Time Frame: 24 hours]
use of antiemetics	each criterion is reported as present or absent each criterion is reported as present or absent	[Time Frame: 24 hours]
discharged	each criterion is reported as when the patient is discharged	[Time Frame: 7 days]

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Sinem Sarı, Aydin Adnan Menderes University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Pain, Postoperative; Low Back Pain
• Other Study ID 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