Lung CancerNCT03879148
Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery
A study testing Erector spinae plane block in people with Lung Cancer, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 30 Apr 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary lung carcinoma
- Must be undergoing VATS lobectomy under general anesthesia
- Must be in American Society of Anesthesiologists (ASA) classification I-II status
Who cannot join
- History of bleeding diathesis,
- History of receiving anticoagulant treatment,
- History of local anesthetics or opioid allergy,
- Skin infection at the site of the needle puncture,
- Presence of pregnancy or lactation, and
- Patients who did not accept the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery: A Prospective, Randomized Study
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to evaluate US-guided ESP block for postoperative analgesia management after VATS.
Read the detailed description
Postoperative pain after thoracic surgery which is attributed to muscle incision, rib retraction, and intercostal nerve damage may be severe such a degree that it may cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. Because video assisted thoracic surgery (VATS) has some advantages over open thoracotomy such as reduced pain, shoulder dysfunction, early pulmonary impairment, rapid recovery, short hospital stay and low complication risk, it has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is a less painful procedure than open thoracotomy, patients may still feel severe pain during the first hours at postoperative period. As thoracic epidural analgesia (TEA) is the gold standard analgesic technique after thoracotomy, it is also being used for analgesia management following VATS. Hence TEA has some difficulties in administration and side effects, minimally invasive analgesic techniques are supported for pain management in patients who underwent VATS. The gold standard minimal invasive analgesic technique for VATS is still be questioned. Thoracic paravertebral block (TPVB) has been evaluated as the first step regional analgesia technique after VATS. However, its administration is difficult because of its anatomical proximity to important structures such as the pleura and central neuro-axial system. Therefore it may cause complications such as pneumothorax and neuro-axial injury. The ultrasound (US) guided erector spina plane block (ESPB) - a novel interfacial plan block defined by Forero et al. in 2016 - has the advantage of being away from the pleural and neurological structures, thus the risk of complications is lower. In the literature, case reports about the analgesic effect of ESPB after thoracotomy and VATS has been increasing. However there is no randomized study for VATS yet. In this study, investigators aimed to evaluate the efficacy of US-guided ESPB for postoperative analgesia management following VATS.
- Conditions
- Lung Cancer
- Being tested
- Erector spinae plane block
- Keywords
- Erector spinae plane block, Video assisted thoracic surgery, Postoperative analgesia
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockOther
Erector spinae plane block was performed to the patients under aseptic conditions
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block (Group I) | Active comparator | The ultrasound (US) guided ESPB was performed under aseptic conditions at the level of T5 vertebrae using the GE Vivid Q® US device. A high frequency 12 MHz linear US probe was covered with a sterile sheath and placed longitudinally 2-3 cm lateral to the T5 transvers process. After visualizing trapezius, rhomboid major, erector spinae muscles superficial to the hyperechoic transverse process shadow respectively, a 22-gauge 50 mm block needle (Braun Stimuplex Ultra 360, Germany) was inserted in a cephalad to caudad direction. Once the needle tip had been placed within the interfacial plane below the erector spinae muscle, 2 mL of saline were injected to confirm the proper injection site, and then a 20 mL dose of 0.25% bupivacaine was injected. Patients received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit Receives: Other: Erector spinae plane block |
| Control group (Group II) | No intervention | Patients in control group only received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption change is being assessed
All patients received fentanyl via a patient controlled analgesia (PCA) device.
Measured: Postoperative 1, 2, 4, 8, 16 and 24 hours
Secondary outcomes (1)
Postoperative pain scores (Visual analoge score-VAS) is being assessed
0 = no pain, 10 = the most severe pain felt
Measured: Postoperative 1, 2, 4, 8, 16 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Sep 2018
- Primary completion28 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- randomized prospective study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879148
- Sponsor's protocol ID
- Medipol University Hospital
- Status last verified
- May 2019
- First submitted
- 12 Mar 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) will not be shared
Publications
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 27501016Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03879148
- Acronym / sponsor ID
- Medipol University Hospital
- Conditions
- Lung Cancer
- Keywords
- Erector spinae plane block, Video assisted thoracic surgery, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to evaluate US-guided ESP block for postoperative analgesia management after VATS.
Detailed description
Postoperative pain after thoracic surgery which is attributed to muscle incision, rib retraction, and intercostal nerve damage may be severe such a degree that it may cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. Because video assisted thoracic surgery (VATS) has some advantages over open thoracotomy such as reduced pain, shoulder dysfunction, early pulmonary impairment, rapid recovery, short hospital stay and low complication risk, it has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is a less painful procedure than open thoracotomy, patients may still feel severe pain during the first hours at postoperative period. As thoracic epidural analgesia (TEA) is the gold standard analgesic technique after thoracotomy, it is also being used for analgesia management following VATS. Hence TEA has some difficulties in administration and side effects, minimally invasive analgesic techniques are supported for pain management in patients who underwent VATS. The gold standard minimal invasive analgesic technique for VATS is still be questioned. Thoracic paravertebral block (TPVB) has been evaluated as the first step regional analgesia technique after VATS. However, its administration is difficult because of its anatomical proximity to important structures such as the pleura and central neuro-axial system. Therefore it may cause complications such as pneumothorax and neuro-axial injury. The ultrasound (US) guided erector spina plane block (ESPB) - a novel interfacial plan block defined by Forero et al. in 2016 - has the advantage of being away from the pleural and neurological structures, thus the risk of complications is lower. In the literature, case reports about the analgesic effect of ESPB after thoracotomy and VATS has been increasing. However there is no randomized study for VATS yet. In this study, investigators aimed to evaluate the efficacy of US-guided ESPB for postoperative analgesia management following VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block (Group I) | Active comparator | Other: Erector spinae plane blockThe ultrasound (US) guided ESPB was performed under aseptic conditions at the level of T5 vertebrae using the GE Vivid Q® US device. A high frequency 12 MHz linear US probe was covered with a sterile sheath and placed longitudinally 2-3 cm lateral to the T5 transvers process. After visualizing trapezius, rhomboid major, erector spinae muscles superficial to the hyperechoic transverse process shadow respectively, a 22-gauge 50 mm block needle (Braun Stimuplex Ultra 360, Germany) was inserted in a cephalad to caudad direction. Once the needle tip had been placed within the interfacial plane below the erector spinae muscle, 2 mL of saline were injected to confirm the proper injection site, and then a 20 mL dose of 0.25% bupivacaine was injected. Patients received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit |
| Control group (Group II) | No intervention | –Patients in control group only received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary lung carcinoma
- Must be undergoing VATS lobectomy under general anesthesia
- Must be in American Society of Anesthesiologists (ASA) classification I-II status
Key exclusion criteria (6 listed)
- History of bleeding diathesis,
- History of receiving anticoagulant treatment,
- History of local anesthetics or opioid allergy,
- Skin infection at the site of the needle puncture,
- Presence of pregnancy or lactation, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockErector spinae plane block was performed to the patients under aseptic conditions | Other | Erector spinae plane block (Group I) |
Primary outcome
Postoperative opioid consumption change is being assessed
Time frame: Postoperative 1, 2, 4, 8, 16 and 24 hours
All patients received fentanyl via a patient controlled analgesia (PCA) device.
1 secondary outcome
Postoperative pain scores (Visual analoge score-VAS) is being assessed
Time frame: Postoperative 1, 2, 4, 8, 16 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- Background: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Individual participant dataSharing planned: No. individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Lung Cancer, run by Medipol 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 3 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: finished, as of the sponsor's last update on 7 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption change is being assessed (time frame: Postoperative 1, 2, 4, 8, 16 and 24 hours). 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 NCT03879148, which also lists 3 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 7 May 2019.