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

Sponsor
Ataturk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04459923
Collaborator
(none)
50
1
2
23.1
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ultrasound-guided erector spinae plane block catheter
  • Procedure: thoracic epidural catheter
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 20, 2020
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
May 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Epidural Catheter Group

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

Procedure: thoracic epidural catheter
for postoperative pain management thoracic epidural catheter placement

Active Comparator: Erector Spina Block Catheter Groups

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.

Procedure: ultrasound-guided erector spinae plane block catheter
for postoperative pain management ultrasound-guided erector spine plane block catheter placement

Outcome Measures

Primary Outcome Measures

  1. VAS [48 hour]

    difference between average VAS scores of epidural and ESP groups

Secondary Outcome Measures

  1. Total fentanyl consumption [48 hour]

    Total fentanyl consumption.

  2. VAS scores [48 hour]

    VAS scores at rest and movement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Yakutiye Turkey 25240

Sponsors and Collaborators

  • Ataturk University

Investigators

  • Principal Investigator: Ilker Ince, MD, Ataturk University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ilker Ince, Associated Prof MD, Ataturk University
ClinicalTrials.gov Identifier:
NCT04459923
Other Study ID Numbers:
  • B.30.2.ATA.0.01.00/290
First Posted:
Jul 7, 2020
Last Update Posted:
Mar 12, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2021