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Pain, AcuteEsPITHXNCT04459923

Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

A study testing ultrasound-guided erector spinae plane block catheter and thoracic epidural catheter in people with Pain, Acute and Opioid Use, run by Ataturk University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pain, Acute, Opioid Use
What is being tested?
ultrasound-guided erector spinae plane block catheter and thoracic epidural catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jun 2020to 25 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kübra SELVİTOPİ contact

+905067303513

drkubra25@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ataturk University

    Erzurum, Yakutiye, 25240

    KÜBRA SELVİTOPİ, 1, +905067303513, drkubra25@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.
Being tested
ultrasound-guided erector spinae plane block catheter, thoracic epidural catheter
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasound-guided erector spinae plane block catheterProcedure or surgery

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

  • thoracic epidural catheterProcedure or surgery

    for postoperative pain management thoracic epidural catheter placement

Study groups in NCT04459923
Study groupRoleWhat they receive
Epidural Catheter GroupActive 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
Receives: Procedure: thoracic epidural catheter
Erector Spina Block Catheter GroupsActive 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.
Receives: Procedure: ultrasound-guided erector spinae plane block catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS

    difference between average VAS scores of epidural and ESP groups

    Measured: 48 hour

Secondary outcomes (2)
  1. Total fentanyl consumption

    Total fentanyl consumption.

    Measured: 48 hour

  2. VAS scores

    VAS scores at rest and movement

    Measured: 48 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start20 Jun 2020
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion25 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459923
Sponsor's protocol ID
B.30.2.ATA.0.01.00/290
Acronym
EsPITHX
Status last verified
Mar 2021
First submitted
30 Jun 2020
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Türk Göğüs Kalp Damar Cer Derg 2009;17(2):139-143

  • 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.

    PubMed 29033355
  • 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.

    PubMed 10989710
  • 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.

    PubMed 27501016

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound-guided erector spinae plane block catheter and thoracic epidural catheter in people with Pain, Acute and Opioid Use, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kübra SELVİTOPİ (+905067303513, drkubra25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS (time frame: 48 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459923, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

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