Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery

NCT03180099 | Unknown Phase 4

• 1 other identifier: ErzurumPSH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:Lomber disc hernia is one of the most common diseases in Turkey. The prevalence in various studies is between 60-80% and incidence is between 1-3% for the entire population,Goal of TLIP is to provide a same impact in the thoracolumbar region, like thoracoabdominal plane block (TAP) diminish the pain in the abdominal surgery Methods: The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 50 patients who were candidated for surgical operations on lumbar disc hernia surgery. . Patients will be divided into two groups as Group T (TLIP block) and Group E (Epidural group).In group T, TLIP block will be applied before anesthesia and surgery and evaluate block efficiency with temperature discrimination and pin-prick test. During the TLIP block, block fluid will have total volume of 20 mL of 0.5% bupivacaine.). In Group E, after surgery, total of 20 ml of 0.1% bupivacaine and 50 mcg of fentanyl will be performed in the epidural space with direct vision by the surgeon.For the postoperative analgesia, patient controlled analgesia device will be administered as 20 mg/h continue dose tramadol and administered 10 mg bolus dose tramadol if patient need a rescue dose. Nausea-vomiting, tramadol consumption, bolus dose intervention and visual analog scale value in the postoperative 0-4., 4-12., and 12-24. hour interval will be assess and results will be record.

Conditions

Postoperative Pain

Keywords

Lumbar Disk Hernia; Thoracolumbar Interfascial Plane Block; Lumbar Disk Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  First 24 hours total fentanyl consumption with patient controlled analgesia

  [Time Frame: First 24 hours total opioid consumption]

Secondary Outcomes (6)

• Visual Analogue Pain Score

  [Time Frame: postoperative first hour]

• Visual Analogue Pain Score

  [Time Frame: postoperative second hour]

• Visual Analogue Pain Score

  [Time Frame: postoperative 4th hour]

• Visual analog pain score

  [Time Frame: postoperative 8th hour]

• Visual analog pain score

  [Time Frame: postoperative 12th hour]

Study Arms (2)

Thoracolumbar Interfascial Plane Block

ACTIVE COMPARATOR

Bilateral ultrasound guided thoracolumbar interfascial plane block

Drug: Bupivacaine

Epidural Block

ACTIVE COMPARATOR

Epidural Block

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Ultrasonically assisted, 0.5-1 mL 0.9% NaCl test is given between m.longissimus and m.iliocostalis to confirm the position of the needle and local anesthetic drugs will be given here

Also known as: Thoracolumbar Interfascial Plane Block

Thoracolumbar Interfascial Plane Block

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 70 years with the American society of anesthesiologists (ASA) physical status classification systems I/II who were candidated for surgical operations on lumbar disc hernia surgery

You may not qualify if:

• have a neurological and neuromuscular disorders, psychiatric problems, cardiopulmoner diseases, coagulopathy, infections or allergy to local anesthetic agents.

Sponsors & Collaborators

• Erzurum Palandöken State Hospital: lead

Study Sites (1)

Erkan Cem ÇELİK

Erzurum, 25080, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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

• Ahiskalioglu A, Alici HA, Selvitopi K, Yayik AM. Ultrasonography-guided modified thoracolumbar interfascial plane block: a new approach. Can J Anaesth. 2017 Jul;64(7):775-776. doi: 10.1007/s12630-017-0851-y. Epub 2017 Feb 27. No abstract available.

  PMID: 28243853 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Erkan C ÇELİK

CONTACT

905053442181; drerkancem@yahoo.com

Ali Ahiskalioglu

CONTACT

905444424831; aliahiskaliioglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consult of Anesthesiologhy

Study Record Dates

• First Submitted: April 29, 2017
• First Posted: June 8, 2017
• Study Start: November 10, 2017
• Primary Completion: November 11, 2017
• Study Completion: December 11, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

TU (1)