Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery
EsPITHX
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2020
CompletedFirst Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedMarch 12, 2021
March 1, 2021
1.5 years
June 30, 2020
March 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
VAS
difference between average VAS scores of epidural and ESP groups
48 hour
Secondary Outcomes (2)
Total fentanyl consumption
48 hour
VAS scores
48 hour
Study Arms (2)
Epidural Catheter Group
ACTIVE COMPARATORPatients 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
Erector Spina Block Catheter Groups
ACTIVE COMPARATORPatients 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.
Interventions
for postoperative pain management ultrasound-guided erector spine plane block catheter placement
for postoperative pain management thoracic epidural catheter placement
Eligibility Criteria
You may qualify if:
- VATS surgery patients
- ASA I-III group
- without any chronic pain or anychronic analgesic usage history
- volunteer to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University
Erzurum, Yakutiye, 25240, Turkey (Türkiye)
Related Publications (4)
Türk Göğüs Kalp Damar Cer Derg 2009;17(2):139-143
BACKGROUNDOkmen 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.
PMID: 29033355BACKGROUNDKaranikolas 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.
PMID: 10989710BACKGROUNDForero 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.
PMID: 27501016BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilker Ince, MD
Ataturk University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Prof MD
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
June 20, 2020
Primary Completion
December 30, 2021
Study Completion
May 25, 2022
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share