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USG Thoracolumbar Interfascial Plane (TLIP) in Lumbar Spine Surgeries

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ClinicalTrials.gov Identifier: NCT03193658
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eslam Ayman Mohamed Shawki, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Regional Anesthesia Procedure: Thoracolumbar Interfascial Plane (TLIP) block Drug: I.V drug based multimodal approach Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled double blinded study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Ultrasound Guided Bilateral Thoracolumbar Interfascial Plane (TLIP) Block on Post-operative Opioid Consumption After Lumbar Spine Surgeries. A Randomized Double Blinded Study.
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : August 1, 2018

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Time of the operation [ Time Frame: 4 hours ]
    Time of the operation (time between induction of anesthesia and full recovery of the patient)

  3. Total intraoperative I.V. fentanyl dose [ Time Frame: 4 hours ]
    Total intraoperative I.V. fentanyl dose (above the standard 2µg/kg).

  4. 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.

  5. 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.

  6. First time of rescue analgesia [ Time Frame: 24 hours ]
    First time of rescue analgesia

  7. 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…..).

  8. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193658


Locations
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Egypt
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo, Egypt
Sponsors and Collaborators
Eslam Ayman Mohamed Shawki

Publications:

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Responsible Party: Eslam Ayman Mohamed Shawki, Lecturer of anesthesia, SICU & Pain Management, Cairo University
ClinicalTrials.gov Identifier: NCT03193658     History of Changes
Other Study ID Numbers: TLIP_spine
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eslam Ayman Mohamed Shawki, Cairo University:
spine surgery
Thoracolumbar Interfascial Plane block
regional anesthesia
postoperative analgesia
opioid consumption

Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents