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Patient Controlled Erector Spinae Block at VATS

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
VIDEO ASSISTED THOTACOSOPIC SURGERY
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Erector Spinae Block,, VATS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages between 20- 75
  • ASA (American Society of Anesthesiologists) Score I-III
  • Undergoing elective Video Assisted Thoracic Surgery

Exclusion Criteria:

  • ASA Score IV and higher
  • Patinets with neurological deficits
  • Paitents who have major vascular damage at the same side
  • Mentally retarded patients
  • Patients with alcohol or drug addiction
  • Patients who are allergic to local anesthetics
  • Pregnancy
  • Paitents with coagulopathy
  • Patients with skin infection at the side of the procedure
  • Patients with pneumothorax at the side of the procedure
  • Patient with a pacemaker

Sites / Locations

  • Zonguldak Bulent Ecevit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Erector Spinae Block for VATS Group

Patient - Controlled Analgesia for VATS Group

Arm Description

40 patients who had VATS will receive erector spinae block for postoperative pain management. All patients will receive IV Midazolam (0.05mg/kg) premediacation. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the induction and in the prone positon the ESB procedure will be done. 10 % povidon- iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identified in the USG the needle will be guided caudally.0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed.

40 patients who had VATS will receive IV PCA for postoperative analgesia managemnet.

Outcomes

Primary Outcome Measures

Perioperative and postoperative analgesic needs of patients
Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.

Secondary Outcome Measures

side effect.
side effects of opioids

Full Information

First Posted
October 2, 2019
Last Updated
May 28, 2021
Sponsor
Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT04121000
Brief Title
Patient Controlled Erector Spinae Block at VATS
Official Title
Effects of Patient Controlled Erector Spinae Block on Postoperative Pain in Video Assisted Thoracoscopic Surgery (VATS) : A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study our aim is to investigate the effects of continue erector spinae block on postoperative pain in patients who underwent thoracoscopic surgery.
Detailed Description
Open thoracic surgeries are very painful procedures. After these procedures multimodal analgesia methods such as NSAIDs, opioids, PCA (patient-controlled analgesia), infiltration analgesia and thoracal epidural block are frequently used. Of these methods thoracal epidural block is the gold standart, however this technique is very invasive and has a high risk for complications. Lately Video Assisted Thoracoscopic Surgery (VATS) has become more popular because it reduces the hospital stay and is less invasive, hence the thoracic epidural block for postoperative pain has become more questionable. In this study we aimed to investigate the effects of continue Erector Spinae Block (ESB) on postoperative pain after VATS. The study will include 80 patients. 40 patients will receive ultrasound (USG) guided ESB and 40 patients will receive PCA. All patients will recive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. Fentanyl (1-2 µg/kg), Propofol (2-3 mg/kg) and Rocuronyum (0,5-0,8 mg/kg) will be given in induction of general anesthesia. Volume -controlled ventilation will be secured to have the values O2 saturation >98% and en-tidal carbondioxide 30-35 mm-Hg. For the mainentanance of general anesthesia the minimal alveolar concentration of sevoflurane will be 1. After the surgery every patient will receive 1 gr paracetemol and 100 mg tramadol for postoperative pain. Furthermore every patient will receive 8 mg ondansetrone for postoperative nausesa. After sedation and standard monitorization, 20 minutes before the induction and in the prone position the Erecor Spinae Block (ESB) procedure will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identifed in the USG the needle will be guided caudally. 0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed. The patients' VAS scores will be evaluated at the 1st,3rd, 6th, 12th, and 24th hours and will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Erector Spinae Block,, VATS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a two-arm parallel assignment. One group will receive erector spinae block and the other will receive PCA.
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Block for VATS Group
Arm Type
Experimental
Arm Description
40 patients who had VATS will receive erector spinae block for postoperative pain management. All patients will receive IV Midazolam (0.05mg/kg) premediacation. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. After sedation and standard monitorization, 20 minutes before the induction and in the prone positon the ESB procedure will be done. 10 % povidon- iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identified in the USG the needle will be guided caudally.0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed.
Arm Title
Patient - Controlled Analgesia for VATS Group
Arm Type
Experimental
Arm Description
40 patients who had VATS will receive IV PCA for postoperative analgesia managemnet.
Intervention Type
Procedure
Intervention Name(s)
VIDEO ASSISTED THOTACOSOPIC SURGERY
Intervention Description
VATS
Primary Outcome Measure Information:
Title
Perioperative and postoperative analgesic needs of patients
Description
Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.
Time Frame
Change in VAS scores at the first 48 hours
Secondary Outcome Measure Information:
Title
side effect.
Description
side effects of opioids
Time Frame
1st, 4rd, 8th,12th, 24th, 36th and 48 th hours after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages between 20- 75 ASA (American Society of Anesthesiologists) Score I-III Undergoing elective Video Assisted Thoracic Surgery Exclusion Criteria: ASA Score IV and higher Patinets with neurological deficits Paitents who have major vascular damage at the same side Mentally retarded patients Patients with alcohol or drug addiction Patients who are allergic to local anesthetics Pregnancy Paitents with coagulopathy Patients with skin infection at the side of the procedure Patients with pneumothorax at the side of the procedure Patient with a pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OZCAN PISKIN
Organizational Affiliation
Bulent Ecevit University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zonguldak Bulent Ecevit University
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient Controlled Erector Spinae Block at VATS

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