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).
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
- Recruiting
Erkan Cem ÇELİK
Erzurum, 25080
Erkan Cem ÇELİK, MD, 5053442181, drerkancem@yahoo.com
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Thoracolumbar Interfascial Plane Block | Active comparator | Bilateral ultrasound guided thoracolumbar interfascial plane block Receives: Drug: Bupivacaine |
| Epidural Block | Active comparator | Epidural Block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: [Time Frame: First 24 hours total opioid consumption]
Secondary outcomes (6)
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]
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]
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]
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]
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]
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.
- First posted8 Jun 2017
- Study start10 Nov 2017 (estimated)
- Primary completion11 Nov 2017 (estimated)
- Study completion11 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erzurum Palandöken State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erkan Cem ÇELİK, Erzurum Palandöken State Hospital
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 26149600Ahiskalioglu 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery
- ClinicalTrials.gov ID
- NCT03180099
- Acronym / sponsor ID
- ErzurumPSH
- Conditions
- Postoperative Pain
- Keywords
- Lumbar Disk Hernia, Thoracolumbar Interfascial Plane Block, Lumbar Disk Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erzurum Palandöken State HospitalOther government
- Study start
- 10 Nov 2017 (estimated)
- Primary completion
- 11 Nov 2017 (estimated)
- Study completion
- 11 Dec 2017 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar Interfascial Plane Block | Active comparator | Drug: BupivacaineBilateral ultrasound guided thoracolumbar interfascial plane block |
| Epidural Block | Active comparator | Drug: BupivacaineEpidural Block |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- have a neurological and neuromuscular disorders, psychiatric problems, cardiopulmoner diseases, coagulopathy, infections or allergy to local anesthetic agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Thoracolumbar Interfascial Plane BlockUltrasonically 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 | Drug | Thoracolumbar Interfascial Plane Block |
| BupivacaineAlso: Epidural Block20 ml %0.1 Bupivacaine administered to Epidural Space | Drug | Epidural Block |
Primary outcome
Opioid Consumption
Time frame: [Time Frame: First 24 hours total opioid consumption]
First 24 hours total fentanyl consumption with patient controlled analgesia
6 secondary outcomes
Visual Analogue Pain Score
Time frame: [Time Frame: postoperative first hour]
Visual Analogue Pain Score
Time frame: [Time Frame: postoperative second hour]
Visual Analogue Pain Score
Time frame: [Time Frame: postoperative 4th hour]
Visual analog pain score
Time frame: [Time Frame: postoperative 8th hour]
Visual analog pain score
Time frame: [Time Frame: postoperative 12th hour]
Visual analog pain score
Time frame: [Time Frame: postoperative 24th hour]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Background: PubMed 26149600Hand 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.
- Results publication: PubMed 28243853Ahiskalioglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.