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出境医 / 临床实验 / Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery (TALIPES)

Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery (TALIPES)

Study Description
Brief Summary:
Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Opioid Use Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Thoracolumbar interfascial plane block
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
 Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
Other Name: Thoracolumbar interfascial plane block
Active Comparator: Erectro spinae plane block
Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
 Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
Other Name: Erector spinae plane block
Outcome Measures
Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: 48 hour ]
    The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.


Secondary Outcome Measures :
  1. Pain intensity score at rest [ Time Frame: 48 hour ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )

  2. Pain intensity score at movement [ Time Frame: 48 hour ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )

  3. Time to first rescue analgesia [ Time Frame: 48 hour ]
    If VAS is greater than 3, 25 mg of meperidine will be administered.

  4. Postoperative nausea and vomiting [ Time Frame: 48 hour ]
    Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)

  5. Patient satisfaction score [ Time Frame: 48 hour ]
    Will be scored between 1-5 (1- very bad 5-very good).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20-75 years
  2. ASA 1-2-3
  3. Patients scheduled for elective surgery

Exclusion Criteria:

  1. Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
  2. Allergy to drugs
  3. Major cardiac disease
  4. Renal failure
  5. Psychiatric disease
  6. Patients who refuse to participate in the study
  7. Chronic back and lower back pain
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Serdar Yeşiltaş +905423632630 syesiltas@bezmialem.edu.tr
Contact: Sinan Yılmaz +905324563023 syilmaz@bezmialem.edu.tr

Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Layout table for investigator information
Principal Investigator: Serdar Yeşiltaş Bezmialem Vakif University
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date October 8, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019) 		Total morphine consumption [ Time Frame: 48 hour ]
The total amount of morphine given by patient controlled analgesia in 48 hours will be recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019) 		Total morphine consumption [ Time Frame: 24 hour ]
The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Pain intensity score at rest [ Time Frame: 48 hour ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
  • Pain intensity score at movement [ Time Frame: 48 hour ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
  • Time to first rescue analgesia [ Time Frame: 48 hour ]
    If VAS is greater than 3, 25 mg of meperidine will be administered.
  • Postoperative nausea and vomiting [ Time Frame: 48 hour ]
    Changes in Numeric Rank Score will be recorded at postoperative 1, 3, 6, 12, 24, 48 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)
  • Patient satisfaction score [ Time Frame: 48 hour ]
    Will be scored between 1-5 (1- very bad 5-very good).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Pain intensity score [ Time Frame: 24 hour ]
    Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at postoperative 1, 6, 12, 24 hour. he NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )
  • Postoperative nausea and vomiting [ Time Frame: 24 hour ]
    Changes in Numeric Rank Score will be recorded at postoperative 1, 6, 12, 24 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery
Official Title  ICMJE Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
Brief Summary Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Opioid Use
Intervention  ICMJE
  • Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Other Name: Thoracolumbar interfascial plane block
  • Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Other Name: Erector spinae plane block
Study Arms  ICMJE
  • Experimental: Thoracolumbar interfascial plane block
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
    Intervention: Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
  • Active Comparator: Erectro spinae plane block
    Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
    Intervention: Procedure: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 20-75 years
  2. ASA 1-2-3
  3. Patients scheduled for elective surgery

Exclusion Criteria:

  1. Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
  2. Allergy to drugs
  3. Major cardiac disease
  4. Renal failure
  5. Psychiatric disease
  6. Patients who refuse to participate in the study
  7. Chronic back and lower back pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Serdar Yeşiltaş +905423632630 syesiltas@bezmialem.edu.tr
Contact: Sinan Yılmaz +905324563023 syilmaz@bezmialem.edu.tr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931343
Other Study ID Numbers  ICMJE S002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Serdar Yeşiltaş, Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serdar Yeşiltaş Bezmialem Vakif University
PRS Account Bezmialem Vakif University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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