Thoracic DiseasesNCT04221880
Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy
A study testing Bupivacaine Hcl 0.25% Inj, Saline Solution for Block and Saline Solution intravenously in people with Thoracic Diseases, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Diseases
- What is being tested?
- Bupivacaine Hcl 0.25% Inj, Saline Solution for Block and Saline Solution intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2021to 15 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery
Who cannot join
- chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient,
- Patients with allergies to one of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Thoracotomy: A Prospective, Randomized, Double-blind Controlled Clinical Trial
Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries.
The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.
- Conditions
- Thoracic Diseases
- Being tested
- Bupivacaine Hcl 0.25% Inj, Saline Solution for Block, Saline Solution intravenously, Lidocaine
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hcl 0.25% InjDrug
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine
Saline Solution for BlockDrug
Ultrasound-guided erector spinae plane block with 20 ml saline
Saline Solution intravenouslyDrug
Same volume saline solution bolus and infusion as Group Lidocaine
LidocaineDrug
1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB | Active comparator | Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as Group Lidocaine) Receives: Drug: Bupivacaine Hcl 0.25% Inj; Drug: Saline Solution intravenously |
| Group Lidocaine | Active comparator | 1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion and, Ultrasound-guided erector spinae plane block with 20 ml saline Receives: Drug: Saline Solution for Block; Drug: Lidocaine |
| Group Control | Sham comparator | Ultrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine) Receives: Drug: Saline Solution for Block; Drug: Saline Solution intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: First 24 hours total opioid consumption
Secondary outcomes (1)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start29 Sep 2021
- Primary completion1 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221880
- Sponsor's protocol ID
- ESP vs Lidocaine
- Status last verified
- May 2022
- First submitted
- 7 Jan 2020
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80.
PubMed 30921979
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Thoracotomy: A Prospective, Randomized, Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04221880
- Acronym / sponsor ID
- ESP vs Lidocaine
- Conditions
- Thoracic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 9 Jan 2020 (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.
Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries.
The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group ESPB | Active comparator | Drug: Bupivacaine Hcl 0.25% Inj, Drug: Saline Solution intravenouslyUltrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as Group Lidocaine) |
| Group Lidocaine | Active comparator | Drug: Saline Solution for Block, Drug: Lidocaine1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion and, Ultrasound-guided erector spinae plane block with 20 ml saline |
| Group Control | Sham comparator | Drug: Saline Solution for Block, Drug: Saline Solution intravenouslyUltrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery
Key exclusion criteria (2 listed)
- chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient,
- Patients with allergies to one of the drugs used in the study.
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 |
|---|---|---|
| Bupivacaine Hcl 0.25% InjUltrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine | Drug | Group ESPB |
| Saline Solution for BlockUltrasound-guided erector spinae plane block with 20 ml saline | Drug | Group Control, Group Lidocaine |
| Saline Solution intravenouslySame volume saline solution bolus and infusion as Group Lidocaine | Drug | Group Control, Group ESPB |
| Lidocaine1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion | Drug | Group Lidocaine |
Primary outcome
Opioid Consumption
Time frame: First 24 hours total opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
1 secondary outcome
Visual analog pain score
Time frame: Postoperative 24 hour
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 16 May 2022.
- Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
- Background: PubMed 30921979Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80.
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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 Bupivacaine Hcl 0.25% Inj, Saline Solution for Block and Saline Solution intravenously in people with Thoracic Diseases, 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 1 inclusion and 2 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 16 May 2022. 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. Some participants in this study may receive a placebo. 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?
Opioid Consumption (time frame: First 24 hours total opioid consumption). 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 NCT04221880, which also lists 2 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 16 May 2022.