USG Thoracolumbar Interfascial Plane (TLIP) in Lumbar Spine Surgeries

October 2, 2018 updated by: Eslam Ayman Mohamed Shawki

Effect of Ultrasound Guided Bilateral Thoracolumbar Interfascial Plane (TLIP) Block on Post-operative Opioid Consumption After Lumbar Spine Surgeries. A Randomized Double Blinded Study.

The study aims to evaluate the effect of US guided bilateral Thoracolumbar Interfascial plane (TLIP) block performed at the level of the lumbar spine surgery (involving 1 up to 3 adjacent lumbar vertebrae) after induction of general anesthesia and before starting the surgery on postoperative opioid consumption by the patients during the first 24 hours postoperative.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Commonly performed spinal surgeries include laminectomies and discectomies, spinal fusions, and instrumentations, scoliosis corrections and spinal tumor excision. Conventional non-minimally invasive spinal surgeries usually involve extensive dissection of subcutaneous tissues, bones, and ligaments and thus can result in a considerable degree of postoperative pain. The severe pain typically last for at least 3 days with the highest pain scores recorded during the first 24 hours postoperative. Pain from the back originates from different tissues such as vertebrae & intervertebral discs, facet joint capsules, dura & nerve root sleeves, ligaments, fascia, and muscles, and it is directly proportional to the number of vertebrae involved in the surgery. Sensations from these structures are carried via the posterior rami of spinal nerves connected to sympathetic & parasympathetic nerves.

Adequate pain management in this period can result in improved functional outcome, early ambulation, early discharge, and preventing the development of chronic pain. Many options exist for this purpose, but each has its limitations and applications. The postoperative multi-modal analgesic approach to these patients include drugs like NSAIDs, acetaminophen, opioids, gabapentinoids and even corticosteroids, but using drugs alone for pain management in these patients can prove to be problematic due to side effects like GIT problems (NSAIDs), urinary retention, respiratory depression , nausea & vomiting (opioids), in addition, prescribing postoperative opioids will be more complicated if the patient was on prolonged preoperative opioid regimen (due to the associated opioid resistance), that's why patients on opioids prior to surgery reported more time postoperatively spent in severe pain (60% versus 38%; p=-0.002).

Multiple loco-regional techniques were explored to help supplement the multi-modal approach to decrease side effects, improve quality of postoperative analgesia, increase patient satisfaction after lumbar spine surgeries and also to be used in Enhanced Recovery After Surgery (ERAS) protocols which aims at minimizing opioid analgesics whenever possible. Via-Catheter techniques considered include patient-controlled epidural analgesia that showed promising results regarding pain control but concerns were raised due to its interference with postoperative assessment of neurological functions & voiding, in addition, it was opposed by many surgeons due to the fact of putting a catheter very near to the surgical field. Also continuous infusion of local anesthetics was explored which resulted in decreased postoperative opioid consumption but also raised concerns due to the catheter being placed very near to the wound.

Single injection methods that were explored in the literature include local anesthetic instillation of the affected nerve roots by the surgeon before wound closure, wound local anesthetic infiltration, and even a single low dose of intrathecal morphine administered by the surgeon into the intrathecal space under direct visualization at the conclusion of the surgery. But none of these methods was widely accepted due to limitations in the duration and adequacy of postoperative analgesia.

US guided Thoracolumbar Interfascial plane (TLIP) block is a novel technique first described in a pilot study on volunteers published by William R. Hand and colleagues in Nov 2015, it was designed to target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature (between the multifidus muscle (MF) and the longissimus muscle (LG)), which is analogous to the Transversus Abdominis plane (TAP) block which targets the ventral rami of the thoracolumbar nerves (between the Transversus Abdominis muscle and the internal oblique muscle).

The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block.

Multiple case reports for TLIP block in lumbar spine surgery were described afterwards, Hironobu Ueshima and colleagues described 2 cases that required no additional postoperative analgesia and no complications, then another 2 cases with nearly the same results, they conducted a cadaveric study to assess the spread of injectate within the plane between the MF and LG muscles using only 5ml of blue dye solution, they verified the spread of the dye to the transverse process of the 3rd lumbar vertebra (level of injection) in all cadavers, so they suggested that the local anesthetic's injectate into the fascial plane between the MF and LG muscles can indeed block the posterior rami of the lumbar nerves.

Finally they explored the continuous variation of the block in another 2 cases with reported pain free duration for 2 days (the duration of the study) and a pinprick anesthesia area covering from L1 to L4 level and no complications.

TLIP block has the potential benefit of blocking sensations from spinal and para-spinal structures involved in the surgical trauma up to 1 level above and below the level of the block (including deeper structures, not only skin and subcutaneous tissues, unlike simple wound infiltration), while also sparing neurological functions of the lower limb (specially the motor functions) and urinary bladder functions (Voiding).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • 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 Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy …).

Exclusion Criteria:

  • Patients on preoperative opioid regimen for more than 1 month.
  • Patients with history of previous surgical operations in the lumbar region.
  • Patients with spinal deformities (eg. Scoliosis…..).
  • Hypersensitivity to Bupivacaine.
  • Extensive Lumbar spine surgeries like large tumour excisions, scoliosis correction or more than 2 level spine fixation.
  • Patients with communication difficulties.
  • Lumbar spine operations that will be performed with the patient in any position other than the prone position.
  • Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).
  • Coagulopathies with prothrombin concentration less than 60% or INR more than 1.5.
  • In-ability to postpone anti-coagulation medications.
  • Infection, injury or a lesion at the block site.
  • ASA class 3 and 4 patients.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group T
Will receive bilateral US guided Thoracolumbar Interfascial Plane (TLIP) block at the proposed level of surgery before the start of the surgery
Procedure: Thoracolumbar Interfascial Plane (TLIP) block

A 10 cm 21G Stimuplex needle (Braun Medical Inc, Bethlehem, PA, USA) will be inserted in a lateral-to-medial orientation with an approximate angle of 30 degrees to the skin. The needle will then be advanced under real-time in-plane ultrasound guidance through the belly of the LG towards the MF. The needle tip will be directed towards the LG/MF interface deep to the midpoint then a total volume of 20 ml of Bupivacaine 0.25% will be incrementally injected with intermittently repeated negative aspiration. Anterior spread of local anesthetic will be viewed as favourable.

The same procedure will be repeated on the left side. The patient will then be disinfected and draped and surgery will be allowed to proceed normally.
Active Comparator: Group O
Will not receive the block and postoperative pain control will be managed by I.V drug based multi-modal approach (Opioid & acetaminophen) only.
Drug: I.V drug based multimodal approach
A base low dose opioid of 5mg morphine I.V every 8 hours. Rescue analgesia will be given to the patient if reported a VAS equal or more than 4 in the form of I.V morphine in 2.5mg increments till VAS returns to 4 or less in addition to 1 gm of oral acetaminophen every 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption in the first 24 hours postoperative
Time Frame: 24 hours postoperative
Total morphine consumption in the first 24 hours postoperative (Above the basal 15mg given to all patients) as an indicator of technique efficiency in improving postoperative analgesia.
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to perform the technique
Time Frame: 30 minutes
Time required to perform the technique (time between the start of US scanning and injection of the second local anesthetic bolus).
30 minutes
Time of the operation
Time Frame: 4 hours
Time of the operation (time between induction of anesthesia and full recovery of the patient)
4 hours
Total intraoperative I.V. fentanyl dose
Time Frame: 4 hours
Total intraoperative I.V. fentanyl dose (above the standard 2µg/kg).
4 hours
VAS value after recovery
Time Frame: 4 hours
VAS value obtained from patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
4 hours
Modified Bromage score value after recovery
Time Frame: 4 hours
Modified Bromage score value in the lower limbs obtained immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
4 hours
First time of rescue analgesia
Time Frame: 24 hours
First time of rescue analgesia
24 hours
Incidence of side effects related to opioid use
Time Frame: 24 hours
Incidence of side effects related to opioid use (postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention…..).
24 hours
Incidence of complications or side-effects related to the block
Time Frame: 24 hours
Incidence of complications or side-effects related to the block (hematoma formation or intravascular injection).
24 hours

Collaborators and Investigators

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

Sponsor

Eslam Ayman Mohamed Shawki

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 (Actual)

August 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TLIP_spine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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