Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery

NCT ID: NCT03180099

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2017-12-11

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.

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.

Conditions

Postoperative Pain

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thoracolumbar Interfascial Plane Block

Bilateral ultrasound guided thoracolumbar interfascial plane block

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: 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

Epidural Block

Epidural Block

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

20 ml %0.1 Bupivacaine administered to Epidural Space

Interventions

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

Intervention Type: DRUG

Bupivacaine

20 ml %0.1 Bupivacaine administered to Epidural Space

Intervention Type: DRUG

Other Intervention Names

Thoracolumbar Interfascial Plane Block; Epidural Block

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erzurum Palandöken State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Erkan Cem ÇELİK

Consult of Anesthesiologhy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erkan Cem ÇELİK

Erzurum, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Erkan C ÇELİK

Role: CONTACT

Phone: 905053442181

Email: drerkancem@yahoo.com

Ali Ahiskalioglu

Role: CONTACT

Phone: 905444424831

Email: aliahiskaliioglu@hotmail.com

Facility Contacts

Erkan Cem ÇELİK, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 26149600 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28243853 (View on PubMed)

Other Identifiers

ErzurumPSH

Identifier Type: -

Identifier Source: org_study_id