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Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery (EsPITHX)

Primary Purpose

Pain, Acute, Opioid Use

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound-guided erector spinae plane block catheter
thoracic epidural catheter
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria:

  • VATS surgery patients
  • ASA I-III group
  • without any chronic pain or anychronic analgesic usage history
  • volunteer to participate in the study

Exclusion Criteria:

  • Patients of ASA IV and above
  • patients with a BMI > 30
  • patients receiving anticoagulant treatments
  • patients having previous neurologic sequellae history
  • patients having previous thoracoctomy history on the same side
  • patients having any allergy against any of the drugs used in the study (paracetamol, non-steroid analgesics and opioids) will be excluded

Sites / Locations

  • Ataturk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epidural Catheter Group

Erector Spina Block Catheter Groups

Arm Description

Patients will be applied with epidural catheter at T 5-6 level and the patient will be injected with an epidural solution containing 15 ml 0.125% bupivacaine through this epidural catheter

Patients will be applied with an erector spina plane block catheter at the T 5-6 level, erector spina plane block will be applied by ultrasound guidance and when the first local anaesthetic dosage block needle is identified under the erector spina muscle 30 ml 0.25% bupivacaine (15 ml bupivacain + 15 ml saline) will be injected.

Outcomes

Primary Outcome Measures

VAS
difference between average VAS scores of epidural and ESP groups

Secondary Outcome Measures

Total fentanyl consumption
Total fentanyl consumption.
VAS scores
VAS scores at rest and movement

Full Information

First Posted
June 30, 2020
Last Updated
March 11, 2021
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04459923
Brief Title
Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery
Acronym
EsPITHX
Official Title
The Effects of the Epidural Catheter and Ultrason-guided Erector Spina Plan Block Catheter on Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
May 25, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery. particiants hypothesis is that continue ESP block catheter application is non-inferior than epidural catheter application in the first post-operative 48 hours regarding post-operative pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on post-operative pain in patients undergoing VATS.
Detailed Description
Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. Literature shows that resections performed with VATS result in shorter hospital stay, lower complication rates, lower mortality rates and similar survivability rates in comparison to thoracotomy. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery. Post-operative pain is a type of acute pain which starts with surgical procedure and ends with tissue recovery. Eliminating this pain is one of the important purposes of anaesthesia. Post-operative analgesia methods may prevent the patient from feeling pain, but there has been no consensus regarding pain management, and generally a multi-modal approach is the most preferable approach. While various methods are used for post-operation analgesia, studies to increase patient satisfaction are still ongoing. Thoracic epidural analgesia (TEA) and paravertebral block are gold standard of analgesia methods for thoracoscopy operations, and these are widely used for VATS procedures. An epidural application generally performed at the level of T5-7 intervertebral space for thoracic surgery. While intra-operative analgesia is also provided using by an epidural catheter, it is also the first preference in post-operative analgesia management. It can be applied by continuous infusion of local anesthetic, or bolus dosages with 4-6 hours intervals. Erector spina plane block (ESPB) is a type of block applied by injection of a local anaesthetic into the interfacial plane under the erector spina muscle, and it is defined as an analgesic method for thoracic neuropathic pain in 2016. The dermatome area it covers varies according to the level of application. It can be applied under USG guidance and its application may be considered less invasive in comparison to thoracic epidural. Due to its easier application it can prove to be a more popular approach in the future. In thoracic surgeries, single-shut at the T5-6 level can be used or multiple shuts at multiple levels can be applied or continue analgesia can be applied by catheter There has been no randomised controlled study comparing epidural versus erector spinae plane block in the literature. particiants hypothesis is that continue ESP block catheter application is non-inferior than epidural catheter application in the first post-operative 48 hours regarding post-operative pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on post-operative pain in patients undergoing VATS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Catheter Group
Arm Type
Active Comparator
Arm Description
Patients will be applied with epidural catheter at T 5-6 level and the patient will be injected with an epidural solution containing 15 ml 0.125% bupivacaine through this epidural catheter
Arm Title
Erector Spina Block Catheter Groups
Arm Type
Active Comparator
Arm Description
Patients will be applied with an erector spina plane block catheter at the T 5-6 level, erector spina plane block will be applied by ultrasound guidance and when the first local anaesthetic dosage block needle is identified under the erector spina muscle 30 ml 0.25% bupivacaine (15 ml bupivacain + 15 ml saline) will be injected.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided erector spinae plane block catheter
Intervention Description
for postoperative pain management ultrasound-guided erector spine plane block catheter placement
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural catheter
Intervention Description
for postoperative pain management thoracic epidural catheter placement
Primary Outcome Measure Information:
Title
VAS
Description
difference between average VAS scores of epidural and ESP groups
Time Frame
48 hour
Secondary Outcome Measure Information:
Title
Total fentanyl consumption
Description
Total fentanyl consumption.
Time Frame
48 hour
Title
VAS scores
Description
VAS scores at rest and movement
Time Frame
48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: VATS surgery patients ASA I-III group without any chronic pain or anychronic analgesic usage history volunteer to participate in the study Exclusion Criteria: Patients of ASA IV and above patients with a BMI > 30 patients receiving anticoagulant treatments patients having previous neurologic sequellae history patients having previous thoracoctomy history on the same side patients having any allergy against any of the drugs used in the study (paracetamol, non-steroid analgesics and opioids) will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra SELVİTOPİ
Phone
+905067303513
Email
drkubra25@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker Ince, MD
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk University
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KÜBRA SELVİTOPİ, 1
Phone
+905067303513
Email
drkubra25@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Türk Göğüs Kalp Damar Cer Derg 2009;17(2):139-143
Results Reference
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PubMed Identifier
29033355
Citation
Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
Results Reference
background
PubMed Identifier
10989710
Citation
Karanikolas M, Swarm RA. Current trends in perioperative pain management. Anesthesiol Clin North Am. 2000 Sep;18(3):575-99. doi: 10.1016/s0889-8537(05)70181-4.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
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Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

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