- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05999253
Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
Comparison of the Effects of Modified Thoracolumbar Interfacial Plane (mTLIP) Block and Erector Spina Plane Block on Postoperative Pain and Opioid Analgesic Consumption in Patients Undergoing Lumbar Discectomy for Lumbar Disc Herniation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.
- 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
- to be administered only approximately 20-30 minutes before the onset of anaesthesia.
- only once in the preoperative block room approximately 20-30 minutes before induction of anaesthesia
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face. Patients will be routinely administered 1 g paracetamol intravenously at 8 hour intervals in the postoperative period. 100 mg tramadol intravenously will be administered if their pain is above VAS 4 despite this.
- This study was followed up in the neurosurgery unit of SBU Gazi Yasargil Training and Research Hospital.
- Patients were sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied.
Patients will be monitored for pain and side effects at the neurosurgery unit , 1st hour, 2nd hour, 4th hour, 8th hour and 24th hour in the postoperative period.
- Both plan blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.
Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.
- 20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
- to be administered only approximately 20-30 minutes before the onset of anaesthesia.
- only once in the preoperative block room approximately 20-30 minutes before induction of anaesthesia
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
- plane blocks will be applied under ultrasound guidance.
- plane block applications will be performed by anaesthesiologists with at least 5 years of experience
- Postoperative evaluations of patients will be performed face to face.
Statistical methods / analysis: G-Power version 3.1.9.4 (Universität Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 72.
SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Fatma Acil, M.D.
- Phone Number: +905337225225
- Email: acilfatma@gmail.com
Study Locations
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Diyarbakır, Turkey, 21070
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients between 18-70 years of age, ASA I-III, scheduled for Lumbar Disc Herniation operation under general anaesthesia.
Exclusion Criteria:
- ASA >III body mass index (BMI) > 35 kg/m2 known allergy to local anaesthetics presence of preoperative chronic pain presence of coagulopathy those who are unable to give written consent non-voluntary patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Modified thoracolumbar plane block (mTLIP)
Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.
|
Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.
Other Names:
|
Erector spinae plane block (ESP)
Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.
|
Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
|
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assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedation- agitation level
Time Frame: After extubation]
|
The Riker Sedation- Agitation Scale (RSAS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior. Riker sedation-agitation Scale:1- Unarousable, 2 -Very Sedated, 3- Sedated, 4 Calm and Cooperative, 5 -Agitated, 6 -Very Agitated, 7 -Dangerous Agitation |
After extubation]
|
Systolic, diastolic and mean arterial pressure monitoring
Time Frame: before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
|
Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
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before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
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heart rate monitoring
Time Frame: before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
|
the measurement will be obtained by electrocardiographic monitoring
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before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
|
amount of fentanyl consumed during the operation
Time Frame: during surgery
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micrograms of fentanyl consumed
|
during surgery
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Amount of tramadol used postoperatively
Time Frame: during the postoperative 24 hour]
|
Amount of tramadol used postoperatively (milligrams)
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during the postoperative 24 hour]
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Surgery duration
Time Frame: at the end of surgery]
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Time in hours from the start of the surgical incision until the last surgical suture is placed
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at the end of surgery]
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Anesthesia duration
Time Frame: at the end of anaesthesia]
|
time in hours from induction of anaesthesia to extubation
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at the end of anaesthesia]
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patient satisfaction assessmen
Time Frame: at the end of 24 hours postoperatively
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Patients' satisfaction with the quality of pain management will be assessed at 24 hours postoperatively using the following scale: 1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfied; 5 = very satisfied |
at the end of 24 hours postoperatively
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Nausea-vomiting
Time Frame: postoperative 1st, 2nd, 4th, 8th and 24th hours
|
-Postoperative nausea and vomiting will be assessed using a 100 mm Visual Analogue Scale (VAS): 1- severe nausea (VAS>70 mm), 2- moderate nausea (50<VAS<70 mm), 3- mild nausea (VAS <50 mm). |
postoperative 1st, 2nd, 4th, 8th and 24th hours
|
Collaborators and Investigators
Investigators
- Study Director: Cem K. Kaçar, Assoc.Prof, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.05.2023/373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- after de-identification; all individual participant data collected during the research and the primary and secondary outcomes of the study.
- data can be shared immediately after publication, no end date set.
- case-by-case basis at the discretion of Primary Sponsor
- data can be access subject to approvals by Principal Investigator (e-mail: fatma.acil@saglik.gov.tr)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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