USG Thoracolumbar Interfascial Plane (TLIP) in Lumbar Spine Surgeries

NCT03193658 | Completed

• 1 other identifier: TLIP_spine
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia

Keywords

spine surgery; Thoracolumbar Interfascial Plane block; regional anesthesia; postoperative analgesia; opioid consumption

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption in the first 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 Outcomes (8)

• Time required to perform the technique

  30 minutes

• Time of the operation

  4 hours

• Total intraoperative I.V. fentanyl dose

  4 hours

• VAS value after recovery

  4 hours

• Modified Bromage score value after recovery

  4 hours

Study Arms (2)

Group T

ACTIVE COMPARATOR

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

Group O

ACTIVE COMPARATOR

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

Interventions

Thoracolumbar Interfascial Plane (TLIP) block PROCEDURE

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.

Group T

I.V drug based multimodal approach DRUG

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

Group O

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eslam Ayman Mohamed Shawki: lead

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (15)

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• Bajwa SJ, Haldar R. Pain management following spinal surgeries: An appraisal of the available options. J Craniovertebr Junction Spine. 2015 Jul-Sep;6(3):105-10. doi: 10.4103/0974-8237.161589.

  PMID: 26288544 BACKGROUND

• Devin CJ, McGirt MJ. Best evidence in multimodal pain management in spine surgery and means of assessing postoperative pain and functional outcomes. J Clin Neurosci. 2015 Jun;22(6):930-8. doi: 10.1016/j.jocn.2015.01.003. Epub 2015 Mar 9.

  PMID: 25766366 BACKGROUND

• Aminmansour B, Khalili HA, Ahmadi J, Nourian M. Effect of high-dose intravenous dexamethasone on postlumbar discectomy pain. Spine (Phila Pa 1976). 2006 Oct 1;31(21):2415-7. doi: 10.1097/01.brs.0000238668.49035.19.

  PMID: 17023848 BACKGROUND

• Tan M, Law LS, Gan TJ. Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways. Can J Anaesth. 2015 Feb;62(2):203-18. doi: 10.1007/s12630-014-0275-x. Epub 2014 Dec 10.

  PMID: 25501696 BACKGROUND

• Schenk MR, Putzier M, Kugler B, Tohtz S, Voigt K, Schink T, Kox WJ, Spies C, Volk T. Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. Anesth Analg. 2006 Nov;103(5):1311-7. doi: 10.1213/01.ane/0000247966.49492.72.

  PMID: 17056975 BACKGROUND

• Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.

  PMID: 24436846 BACKGROUND

• Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.

  PMID: 18425538 BACKGROUND

• Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

  PMID: 26149600 BACKGROUND

• Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.

  PMID: 22260370 BACKGROUND

• Kumar A, Sinha C, Kumar A, Bhadani UK. Ultrasound-guided thoracolumbar interfascial plane block for spine surgery. Saudi J Anaesth. 2017 Apr-Jun;11(2):248-249. doi: 10.4103/1658-354X.203052. No abstract available.

  PMID: 28442976 BACKGROUND

• Ueshima H, Oku K, Otake H. Ultrasound-guided thoracolumbar interfascial plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2016 Nov;34:259-60. doi: 10.1016/j.jclinane.2016.04.060. Epub 2016 May 13. No abstract available.

  PMID: 27687388 BACKGROUND

• Ueshima H, Hiroshi O. RETRACTED: Clinical experiences of the continuous thoracolumbar interfascial plane (TLIP) block. J Clin Anesth. 2016 Nov;34:555-556. doi: 10.1016/j.jclinane.2016.06.004. Epub 2016 Jul 19. No abstract available.

  PMID: 27687450 BACKGROUND

• Breen TW, Shapiro T, Glass B, Foster-Payne D, Oriol NE. Epidural anesthesia for labor in an ambulatory patient. Anesth Analg. 1993 Nov;77(5):919-24. doi: 10.1213/00000539-199311000-00008.

  PMID: 8214727 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, SICU & Pain Management

Model Details: Randomized controlled double blinded study

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: August 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Locations

EG (1)