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

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spinae plane block
Control group
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring spine surgery, postoperative pain, perioperative analgesia, postoperative opioid requirement

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Under direct vision erector spinae plane block

Control group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Total morphine consumption
The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded

Secondary Outcome Measures

Pain intensity score
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
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)

Full Information

First Posted
May 21, 2019
Last Updated
September 6, 2021
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03960528
Brief Title
The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery
Acronym
ESPOUSES
Official Title
Investigation of Erector Spinae Plane Block Effect in Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
spine surgery, postoperative pain, perioperative analgesia, postoperative opioid requirement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Under direct vision erector spinae plane block
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ESP block
Intervention Description
Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.
Intervention Type
Procedure
Intervention Name(s)
Control group
Other Intervention Name(s)
Sham comparator
Intervention Description
20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pain intensity score
Description
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 )
Time Frame
1 day
Title
Postoperative nausea and vomiting
Description
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)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20-75 years ASA 1-2-3 Patients scheduled for elective surgery Exclusion Criteria: Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.) Allergy to drugs Major cardiac disease Renal failure Psychiatric disease Patients who refuse to participate in the study Chronic back and lower back pain Body mass index <18.5 and >40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar YEŞİLTAŞ, Instructor
Organizational Affiliation
BEZMİALEM VAKIF UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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