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出境医 / 临床实验 / The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery (ESPOUSES)

The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery (ESPOUSES)

Study Description
Brief Summary:
Spine surgery is typically associated with severe postoperative pain. Although the number of spine surgeries has increased day by day, postoperative pain management have been limited. The recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the erector spinae 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. The erector spinae muscles are easily identified during spine surgery, and erector spinae plane blocks can be performed under direct vision rather than via ultrasound guidance or simply using anatomical landmarks. Therefore, the investigators aim to observe the efficacy of the under direct vision erector spinae plane block on pain scores after spinal surgery.

Condition or disease Intervention/treatment Phase
Acute Pain Procedure: Erector spinae plane block Procedure: Control group Not Applicable

Detailed Description:

Approval from the university local ethics committee will be obtained. Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 2 mg / kg and rocuronium 0.6 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 2-3% in 50% O2/50% medical air and remifentanil infusion of 0.1-0.5 mcg / kg / min. Thirty minutes before end of the surgery, all patients were intravenously administered 1 mg/kg tramadol HCl and 1gr paracetamol.

Under direct vision ESPB technique: Erector spinae muscles and transverse processes will be identified by the surgeon. At the end of the surgery 20 ml bupivacaine 0.25%/lidocaine 1% mixture will be injected to the between of the erector spinae muscles and transverse processes bilaterally. In the sham comparator group, 20 ml of isotonic saline will be administered bilaterally by the surgeon as described above.

After the surgery, 1 g paracetamol was intravenously administered once every 8 h. A patient-controlled analgesia (PCA) device, which was prepared using morphine, was attached to the patients and was programmed to administer concentration 0.5mg / ml ( 2cc bolus 8 min lock time 2cc/h infusion). This administration continued for 24 h. Postoperative pain was assessed using visuel analog scale (VAS) (VAS 0 = no pain, VAS 10 = most severe pain ). Duration at postanesthesia care unit (PACU) was recorded right from 0 h. VAS scores at 0, 1, 6, 12 and 24 h were recorded. Postoperative nausea and vomiting (PONV) was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of Erector Spinae Plane Block Effect in Spine Surgery
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : February 10, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Under direct vision erector spinae plane block

20 ml bupivacaine 0,25%+ lidocaine 1% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

Procedure: Erector spinae plane block
Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.
Other Name: ESP block

Sham Comparator: Control group

20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

Procedure: Control group
20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.
Other Name: Sham comparator

Outcome Measures
Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: 1 day ]
    The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded


Secondary Outcome Measures :
  1. Pain intensity score [ Time Frame: 1 day ]
    Changes in Numeric Rating Scale (NRS) will be recorded at postoperative 1, 6, 12, 24 hour. The 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. Postoperative nausea and vomiting [ Time Frame: 1 day ]
    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)


Eligibility Criteria
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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
  8. Body mass index <18.5 and >40
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Serdar Yeşiltaş, Instructor +905423632630 syesiltas@bezmialem.edu.tr
Contact: Serdar Yeşiltaş, Instructor +905423632630 drserdaryesiltas@hotmail.com

Locations
Layout table for location information
Turkey
Bezmialem Vakıf University Recruiting
Istanbul, Turkey, 34093
Contact: Serdar Yeşiltaş    +90 542 363 26 30    syesiltas@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Layout table for investigator information
Principal Investigator: Serdar YEŞİLTAŞ, Instructor BEZMİALEM VAKIF UNIVERSITY
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE April 18, 2019
Estimated Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Total morphine consumption [ Time Frame: 1 day ]
The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Pain intensity score [ Time Frame: 1 day ]
    Changes in Numeric Rating Scale (NRS) will be recorded at postoperative 1, 6, 12, 24 hour. The 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: 1 day ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery
Official Title  ICMJE Investigation of Erector Spinae Plane Block Effect in Spine Surgery
Brief Summary Spine surgery is typically associated with severe postoperative pain. Although the number of spine surgeries has increased day by day, postoperative pain management have been limited. The recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the erector spinae 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. The erector spinae muscles are easily identified during spine surgery, and erector spinae plane blocks can be performed under direct vision rather than via ultrasound guidance or simply using anatomical landmarks. Therefore, the investigators aim to observe the efficacy of the under direct vision erector spinae plane block on pain scores after spinal surgery.
Detailed Description

Approval from the university local ethics committee will be obtained. Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 2 mg / kg and rocuronium 0.6 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 2-3% in 50% O2/50% medical air and remifentanil infusion of 0.1-0.5 mcg / kg / min. Thirty minutes before end of the surgery, all patients were intravenously administered 1 mg/kg tramadol HCl and 1gr paracetamol.

Under direct vision ESPB technique: Erector spinae muscles and transverse processes will be identified by the surgeon. At the end of the surgery 20 ml bupivacaine 0.25%/lidocaine 1% mixture will be injected to the between of the erector spinae muscles and transverse processes bilaterally. In the sham comparator group, 20 ml of isotonic saline will be administered bilaterally by the surgeon as described above.

After the surgery, 1 g paracetamol was intravenously administered once every 8 h. A patient-controlled analgesia (PCA) device, which was prepared using morphine, was attached to the patients and was programmed to administer concentration 0.5mg / ml ( 2cc bolus 8 min lock time 2cc/h infusion). This administration continued for 24 h. Postoperative pain was assessed using visuel analog scale (VAS) (VAS 0 = no pain, VAS 10 = most severe pain ). Duration at postanesthesia care unit (PACU) was recorded right from 0 h. VAS scores at 0, 1, 6, 12 and 24 h were recorded. Postoperative nausea and vomiting (PONV) was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Procedure: Erector spinae plane block
    Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.
    Other Name: ESP block
  • Procedure: Control group
    20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.
    Other Name: Sham comparator
Study Arms  ICMJE
  • Active Comparator: Under direct vision erector spinae plane block

    20 ml bupivacaine 0,25%+ lidocaine 1% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

    Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

    Intervention: Procedure: Erector spinae plane block
  • Sham Comparator: Control group

    20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

    Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

    Intervention: Procedure: Control group
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2020
Estimated Primary Completion Date January 10, 2020   (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
  8. Body mass index <18.5 and >40
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, Instructor +905423632630 syesiltas@bezmialem.edu.tr
Contact: Serdar Yeşiltaş, Instructor +905423632630 drserdaryesiltas@hotmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960528
Other Study ID Numbers  ICMJE S003
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 Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serdar YEŞİLTAŞ, Instructor BEZMİALEM VAKIF UNIVERSITY
PRS Account Bezmialem Vakif University
Verification Date December 2019

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