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Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery

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ClinicalTrials.gov Identifier: NCT03180099
Recruitment Status : Unknown
Verified November 2017 by Erkan Cem ÇELİK, Erzurum Palandöken State Hospital.
Recruitment status was:  Recruiting
First Posted : June 8, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Erkan Cem ÇELİK, Erzurum Palandöken State Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine Phase 4

Detailed Description:

Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery 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, If adequate analgesia isn't achieved in postoperative period, the patients can faced with postoperative pain due to lomber disc hernia. In fact, as a result of inadequate analgesia chronic pain can be develop, and patients can be suffered by this pain for long years Thoracolumbar interfascial blok, was defined by Hand et al, descibed for reduce pain of thoracolumbar region surgery. After afferent fibers separate from medulla spinalis, they're called r.anterior and r.posterior. While r. anterior spreads to anterior abdominal wall, r.posterior spreads to thoracolumbar region. 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.

The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 50 patients aged between 18 and 65 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. All the participants will be asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study. Patients will excluded from the study if they have a neurological and neuromuscular disorders, psychiatric problems, cardiopulmoner diseases, coagulopathy, infections or allergy to local anesthetic agents. Patients will be divided into two groups as Group T (TLIP block) and Group E (Epidural group).

Prior to the study, a power analysis was performed to determine the necessary number of patients in each group. With a two-sided type I error of 5% and study power at 80%, it was estimated that 25 patients would be needed in each group 20 gauge cannulas are placed over the left hand of the patient in the operating room and 4 ml kg-1% 0.9% NaCl infusion will be made. The age, weight and sex of the patients will record and the ECG, SpO2, non-invasive blood pressure monitor will be used as standard in the operating room. Routine anesthesia induction in both groups will be performed with 2 mg kg-1 propofol 50 mcg fentanyl and 0.6 mg kg-1 rocuronium anesthesia with 40/60% O2 / N2O 2% sevofloran.

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. TLIP block implementation will be made in accordance with the asepsis antisepsis rules. 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 (according to new approach). 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. After, patients will be administered with 0,01 mg kg atropine iv and 0,02 mg kg neostigmine iv and extubated at the end of the surgery, they will be taken to PACU. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery
Estimated Study Start Date : November 10, 2017
Estimated Primary Completion Date : November 11, 2017
Estimated Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thoracolumbar Interfascial Plane Block
Bilateral ultrasound guided thoracolumbar interfascial plane block
Drug: Bupivacaine
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
Other Name: Thoracolumbar Interfascial Plane Block

Active Comparator: Epidural Block
Epidural Block
Drug: Bupivacaine
20 ml %0.1 Bupivacaine administered to Epidural Space
Other Name: Epidural Block




Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: [Time Frame: First 24 hours total opioid consumption] ]
    First 24 hours total fentanyl consumption with patient controlled analgesia


Secondary Outcome Measures :
  1. Visual Analogue Pain Score [ Time Frame: [Time Frame: postoperative first hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively

  2. Visual Analogue Pain Score [ Time Frame: [Time Frame: postoperative second hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.

  3. Visual Analogue Pain Score [ Time Frame: [Time Frame: postoperative 4th hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively

  4. Visual analog pain score [ Time Frame: [Time Frame: postoperative 8th hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively

  5. Visual analog pain score [ Time Frame: [Time Frame: postoperative 12th hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.

  6. Visual analog pain score [ Time Frame: [Time Frame: postoperative 24th hour] ]
    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT03180099


Contacts
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Contact: Erkan C ÇELİK 905053442181 drerkancem@yahoo.com
Contact: Ali Ahiskalioglu 905444424831 aliahiskaliioglu@hotmail.com

Locations
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Turkey
Erkan Cem ÇELİK Recruiting
Erzurum, Turkey, 25080
Contact: Erkan Cem ÇELİK, MD    5053442181    drerkancem@yahoo.com   
Sponsors and Collaborators
Erzurum Palandöken State Hospital
Publications of Results:
Other Publications:
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Responsible Party: Erkan Cem ÇELİK, Consult of Anesthesiologhy, Erzurum Palandöken State Hospital
ClinicalTrials.gov Identifier: NCT03180099    
Other Study ID Numbers: ErzurumPSH
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

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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
Keywords provided by Erkan Cem ÇELİK, Erzurum Palandöken State Hospital:
Lumbar Disk Hernia
Thoracolumbar Interfascial Plane Block
Lumbar Disk Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents