Continuous Erector Spinae Plane BlockPhase 4NCT06750627
Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy
A Phase 4 study testing Continuous Erector Spinae Plane Block and Multimodal Intravenous Analgesia in people with Continuous Erector Spinae Plane Block and Unilateral Thoracotomy, run by Udayana University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Continuous Erector Spinae Plane Block, Unilateral Thoracotomy
- What is being tested?
- Continuous Erector Spinae Plane Block and Multimodal Intravenous Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to 31 May 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 21-65 years of age
- Undergoing Unilateral Thoracotomy Operation
Who cannot join
- Patients with ASA Physical Status > III
- Obese or Underweight Patients with BMI of less than 18.5 or more than 29.99
- Patients with contraindications to be given local anesthesia drugs
- Patients with contraindications to be given opioid drugs
- Patients refused to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
RSUP Prof. dr. I.G.N.G. Ngoerah
Denpasar, Bali, 80113
Bagian Pendidikan dan Penelitian RSUP Sanglah, +62361244548, info@unud.ac.id
Albert Adipurnama, +6282146551032, albertadipurnama@icloud.com
About this study
The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. The main questions it aims to answer are:
- Does continuous ESPB lower the intensity of postoperative pain compared to multimodal intravenous analgesia?
- Does continuous ESPB increase the time to first analgesic request?
- Does continuous ESPB reduce the amount of intravenous opioids required in the first 48 hours after surgery?
- Does continuous ESPB improve the overall recovery quality within 48 hours post-surgery?
Read more
Participants will:
- Receive continuous ESPB or multimodal intravenous analgesia after the surgery.
- Undergo routine pain assessments, and recovery evaluations using tools like the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15).
- Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.
Read the detailed description
For the Continuous ESPB Group, patients will receive continuous ESPB, NSAIDs, Paracetamol, and Morphine using Patient Controlled Analgesia (PCA) with a demand only mode.
For the Intravenous Opioid, patient will receive Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Paracetamol, and Morphine using Patient Controlled Analgesia (PCA).
- Being tested
- Continuous Erector Spinae Plane Block, Multimodal Intravenous Analgesia
- Keywords
- Erector Spinae Plane Block, Unilateral Thoracotomy, Regional Anesthesia, Continuous Peripheral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
Catheter are placed between the erector spinae muscle and the transversus processus with ultrasound guidance, blocking the dorsal and ventral ramus from the thorax and abdominal spinal nerves, at the level of T5. Local anesthesia is injected. Drugs used are Bupivacaine 0.25% with volume of 25 ml.
Multimodal Intravenous AnalgesiaDrug
Multimodal intravenous analgesia refers to the use of multiple intravenous (IV) agents with different mechanisms of action to provide effective pain relief. The goal is to achieve synergistic effects that improve analgesia while minimizing the doses of individual drugs, thereby reducing side effects. This approach is often used in perioperative and acute pain management.
Patient will receive combinations of opioid through Patient Controlled Analgesia (PCA) device, NSAIDs, and Paracetamol (Acetaminophen)
| Study group | Role | What they receive |
|---|---|---|
| Continuous Erector Spinae Plane Block | Active comparator | Participants will:
* Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15).
* Receive continuous ESPB for analgesia with USG guidance after the surgery.
* Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol
* NSAIDs used is ketorolac, with dose of 30 mg every 8 hours
* Paracetamol 1000 mg every 8 hours will be given
* The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours
* Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality. Receives: Procedure: Continuous Erector Spinae Plane Block |
| Multimodal Intravenous Analgesia | Active comparator | Participants will:
* Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15).
* Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol
* NSAIDs used will be ketorolac of 30 mg every 8 hours
* Paracetamol 1g every 8 hours will be given
* The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours.
* Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality. Receives: Drug: Multimodal Intravenous Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Pain Score 24 hours
Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Measured: 24 hours
Resting Pain Score 48 hours
Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Measured: 48 hours
Coughing Pain Score 24 hours
Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Measured: 24 hours
Coughing Pain Score 48 hours
Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Measured: 48 hours
Secondary outcomes (6)
Time to First Analgesia
First Time to Analgesia is the time recorded since patient went out from the Recovery Room to the time the patient first pressed the demand button on the Patient Controlled Analgesia device. The time will be recorded in hours.
Measured: 48 hours
Opioid Consumption 24 hours
Opioid consumption is the total dose that is needed by the patient during a designated time frame to achieve or maintain adequate analgesic. This will be recorded after 24 hours and 48 hours after the surgery from the Patient Controlled Analgesia device and will be expressed in Mg Morphine Equivalent (MME)
Measured: 24 hours
Opioid Consumption 48 hours
Opioid consumption is the total dose that is needed by the patient during a designated time frame to achieve or maintain adequate analgesic. This will be recorded after 24 hours and 48 hours after the surgery from the Patient Controlled Analgesia device and will be expressed in Mg Morphine Equivalent (MME)
Measured: 48 hours
Quality of Recovery Preoperative
Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. The questionnaire will be given before the surgery.
Measured: At enrollment
Quality of Recovery 24 hours
Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. This questionnaire will be given 24 hours after the surgery
Measured: 24 hours
Quality of Recovery 48 hours
Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. The questionnaire will be given 48 hours after the surgery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Continuous Erector Spinae Plane BlockStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jancolin Yani, Udayana University
- Investigators
- Tjokorda Gde Agung Senapathi, Professor, Study director, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750627
- Sponsor's protocol ID
- 2708/UN14.2.2.VII.14/LT/2024
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be deidentified and maybe shared through the author's email after there are formal request through the principal investigator email. The request must contain the intentions for the use of the data (example: for Meta-Analysis purpose)
Publications
Moorthy A, Ni Eochagain A, Dempsey E, Wall V, Marsh H, Murphy T, Fitzmaurice GJ, Naughton RA, Buggy DJ. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial. Br J Anaesth. 2023 Jan;130(1):e137-e147. doi: 10.1016/j.bja.2022.07.051. Epub 2022 Sep 13.
PubMed 36109206Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available.
PubMed 37465231Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.
PubMed 34301447Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.
PubMed 29746445Gupta R, Van de Ven T, Pyati S. Post-Thoracotomy Pain: Current Strategies for Prevention and Treatment. Drugs. 2020 Nov;80(16):1677-1684. doi: 10.1007/s40265-020-01390-0.
PubMed 32876936Forero 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 27501016Fawzi Hanna, M.E., Abdel Latif, S.A.M., Hussien Maamoon, R.M., Abdel-Mouty Taher, I.A.-A., 2024. Erector Spinae Plane Block for Postoperative Analgesia after Video-Assisted Thoracoscopic Surgery (VATS). QJM: An International Journal of Medicine 117, hcae070.062. https://doi.org/10.1093/qjmed/hcae070.062
De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
PubMed 30621377Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.
PubMed 30113699Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
PubMed 28188621Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.
PubMed 30099210Briscoe JB, Caso R. Pain control after thoracic surgery begins in the operating room. J Thorac Dis. 2022 Aug;14(8):2745-2747. doi: 10.21037/jtd-22-968. No abstract available.
PubMed 36071777Cao C, Zhu ZH, Yan TD, Wang Q, Jiang G, Liu L, Liu D, Wang Z, Shao W, Black D, Zhao Q, He J. Video-assisted thoracic surgery versus open thoracotomy for non-small-cell lung cancer: a propensity score analysis based on a multi-institutional registry. Eur J Cardiothorac Surg. 2013 Nov;44(5):849-54. doi: 10.1093/ejcts/ezt406. Epub 2013 Aug 15.
PubMed 23956268
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy
- ClinicalTrials.gov ID
- NCT06750627
- Acronym / sponsor ID
- 2708/UN14.2.2.VII.14/LT/2024
- Keywords
- Erector Spinae Plane Block, Unilateral Thoracotomy, Regional Anesthesia, Continuous Peripheral Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. The main questions it aims to answer are:
- Does continuous ESPB lower the intensity of postoperative pain compared to multimodal intravenous analgesia?
- Does continuous ESPB increase the time to first analgesic request?
- Does continuous ESPB reduce the amount of intravenous opioids required in the first 48 hours after surgery?
- Does continuous ESPB improve the overall recovery quality within 48 hours post-surgery?
Participants will:
- Receive continuous ESPB or multimodal intravenous analgesia after the surgery.
- Undergo routine pain assessments, and recovery evaluations using tools like the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15).
- Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.
Detailed description
For the Continuous ESPB Group, patients will receive continuous ESPB, NSAIDs, Paracetamol, and Morphine using Patient Controlled Analgesia (PCA) with a demand only mode.
For the Intravenous Opioid, patient will receive Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Paracetamol, and Morphine using Patient Controlled Analgesia (PCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Continuous Erector Spinae Plane Block | Active comparator | Procedure: Continuous Erector Spinae Plane BlockParticipants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive continuous ESPB for analgesia with USG guidance after the surgery. * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used is ketorolac, with dose of 30 mg every 8 hours * Paracetamol 1000 mg every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality. |
| Multimodal Intravenous Analgesia | Active comparator | Drug: Multimodal Intravenous AnalgesiaParticipants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used will be ketorolac of 30 mg every 8 hours * Paracetamol 1g every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours. * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of 21-65 years of age
- Undergoing Unilateral Thoracotomy Operation
Key exclusion criteria (5 listed)
- Patients with ASA Physical Status > III
- Obese or Underweight Patients with BMI of less than 18.5 or more than 29.99
- Patients with contraindications to be given local anesthesia drugs
- Patients with contraindications to be given opioid drugs
- Patients refused to participate
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 |
|---|---|---|
| Continuous Erector Spinae Plane BlockAlso: ESPBCatheter are placed between the erector spinae muscle and the transversus processus with ultrasound guidance, blocking the dorsal and ventral ramus from the thorax and abdominal spinal nerves, at the level of T5. Local anesthesia is injected. Drugs used are Bupivacaine 0.25% with volume of 25 ml. | Procedure or surgery | Continuous Erector Spinae Plane Block |
| Multimodal Intravenous AnalgesiaMultimodal intravenous analgesia refers to the use of multiple intravenous (IV) agents with different mechanisms of action to provide effective pain relief. The goal is to achieve synergistic effects that improve analgesia while minimizing the doses of individual drugs, thereby reducing side effects. This approach is often used in perioperative and acute pain management. Patient will receive combinations of opioid through Patient Controlled Analgesia (PCA) device, NSAIDs, and Paracetamol (Acetaminophen) | Drug | Multimodal Intravenous Analgesia |
Primary outcome
Resting Pain Score 24 hours
Time frame: 24 hours
Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Resting Pain Score 48 hours
Time frame: 48 hours
Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Coughing Pain Score 24 hours
Time frame: 24 hours
Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Coughing Pain Score 48 hours
Time frame: 48 hours
Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
6 secondary outcomes
Time to First Analgesia
Time frame: 48 hours
Opioid Consumption 24 hours
Time frame: 24 hours
Opioid Consumption 48 hours
Time frame: 48 hours
Quality of Recovery Preoperative
Time frame: At enrollment
Quality of Recovery 24 hours
Time frame: 24 hours
Quality of Recovery 48 hours
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 36109206Moorthy A, Ni Eochagain A, Dempsey E, Wall V, Marsh H, Murphy T, Fitzmaurice GJ, Naughton RA, Buggy DJ. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial. Br J Anaesth. 2023 Jan;130(1):e137-e147. doi: 10.1016/j.bja.2022.07.051. Epub 2022 Sep 13.
- Background: PubMed 37465231Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available.
- Background: PubMed 34301447Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.
- Background: PubMed 29746445Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.
- Background: PubMed 32876936Gupta R, Van de Ven T, Pyati S. Post-Thoracotomy Pain: Current Strategies for Prevention and Treatment. Drugs. 2020 Nov;80(16):1677-1684. doi: 10.1007/s40265-020-01390-0.
- 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.
- BackgroundFawzi Hanna, M.E., Abdel Latif, S.A.M., Hussien Maamoon, R.M., Abdel-Mouty Taher, I.A.-A., 2024. Erector Spinae Plane Block for Postoperative Analgesia after Video-Assisted Thoracoscopic Surgery (VATS). QJM: An International Journal of Medicine 117, hcae070.062. https://doi.org/10.1093/qjmed/hcae070.062
- Background: PubMed 30621377De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
- Background: PubMed 30113699Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.
- Background: PubMed 28188621Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
- Background: PubMed 30099210Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.
- Background: PubMed 36071777Briscoe JB, Caso R. Pain control after thoracic surgery begins in the operating room. J Thorac Dis. 2022 Aug;14(8):2745-2747. doi: 10.21037/jtd-22-968. No abstract available.
- Individual participant dataSharing planned: Undecided. The data will be deidentified and maybe shared through the author's email after there are formal request through the principal investigator email. The request must contain the intentions for the use of the data (example: for Meta-Analysis purpose)
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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.
Tjokorda Gde Agung Senapathi, Professor study director
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Erector Spinae Plane Block and Multimodal Intravenous Analgesia in people with Continuous Erector Spinae Plane Block and Unilateral Thoracotomy, run by Udayana University at 1 site in Indonesia.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Dec 2024. 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jancolin Yani, Medical Doctor (+628128781619, jancolinyani@student.unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Pain Score 24 hours (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT06750627, which also lists 13 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 31 Dec 2024.