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Postoperative PainPhase 4NCT03180099

Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery

A Phase 4 study testing Bupivacaine in people with Postoperative Pain, run by Erzurum Palandöken State Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Nov 2017to 11 Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Erkan Cem ÇELİK

    Erzurum, 25080

    Erkan Cem ÇELİK, MD, 5053442181, drerkancem@yahoo.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Bupivacaine
Keywords
Lumbar Disk Hernia, Thoracolumbar Interfascial Plane Block, Lumbar Disk Surgery
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

    Also called Thoracolumbar Interfascial Plane Block

    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

  • BupivacaineDrug

    Also called Epidural Block

    20 ml %0.1 Bupivacaine administered to Epidural Space

Study groups in NCT03180099
Study groupRoleWhat they receive
Thoracolumbar Interfascial Plane BlockActive comparatorBilateral ultrasound guided thoracolumbar interfascial plane block
Receives: Drug: Bupivacaine
Epidural BlockActive comparatorEpidural Block
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    Measured: [Time Frame: First 24 hours total opioid consumption]

Secondary outcomes (6)
  1. Visual Analogue Pain Score

    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

    Measured: [Time Frame: postoperative first hour]

  2. Visual Analogue Pain Score

    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.

    Measured: [Time Frame: postoperative second hour]

  3. Visual Analogue Pain Score

    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

    Measured: [Time Frame: postoperative 4th hour]

  4. Visual analog pain score

    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

    Measured: [Time Frame: postoperative 8th hour]

  5. Visual analog pain score

    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.

    Measured: [Time Frame: postoperative 12th hour]

  6. Visual analog pain score

    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

    Measured: [Time Frame: postoperative 24th hour]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study start10 Nov 2017 (estimated)
  3. Primary completion11 Nov 2017 (estimated)
  4. Study completion11 Dec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180099
Sponsor's protocol ID
ErzurumPSH
Status last verified
Nov 2017
First submitted
29 Apr 2017
Last updated
13 Nov 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26149600
  • 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.

    PubMed 28243853

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine in people with Postoperative Pain, run by Erzurum Palandöken State Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erkan C ÇELİK (905053442181, drerkancem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Consumption (time frame: [Time Frame: First 24 hours total opioid consumption]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03180099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.

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