Breast CancerNCT07562945
Effect of Continuous Erector Spinae Plane Block With Ropivacaine on Postoperative Pain and NF-κB Levels After Mastectomy
A study testing Continuous Erector Spinae Plane Block and Ropivacaine in people with Breast Cancer and Postoperative Pain, Acute, run by Aldy Aldy at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain, Acute
- What is being tested?
- Continuous Erector Spinae Plane Block and Ropivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2026to 1 Oct 2026
- Phase
- Interventional
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 to 65 years
- Diagnosed with breast cancer
- Scheduled for elective mastectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Able to understand and provide written informed consent
- Body mass index (BMI) 18-29 kg/m²
Who cannot join
- Contraindications to regional anesthesia
- Contraindications or allergy to ropivacaine or local anesthetics
- Inability to use a visual analog scale (VAS) for pain assessment
- Inability to understand or operate patient-controlled analgesia (PCA)
- History of chronic pain or ongoing infection requiring treatment
- History of chronic analgesic use
- History of autoimmune disease
- Uncontrolled systemic disease
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
Ngoerah Hospital
Denpasar, Bali, 80113
Aldy Aldy, MD, +6285221222111, aldychen94@gmail.com
About this study
Official title: Comparison of Continuous Erector Spinae Plane Block With Ropivacaine Versus No Block on Postoperative Pain, NF-κB Levels, Opioid Consumption, and Quality of Recovery in Patients Undergoing Elective Mastectomy
This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.
Read the detailed description
Breast cancer is one of the most common malignancies worldwide and frequently requires surgical management in the form of mastectomy. Postoperative pain following mastectomy remains a significant clinical problem, with a substantial proportion of patients experiencing moderate to severe pain. Inadequate pain control is associated with increased opioid consumption, delayed recovery, and a higher risk of developing chronic pain.
The inflammatory response plays an important role in postoperative pain, particularly through the activation of nuclear factor kappa B (NF-κB), a key transcription factor that regulates pro-inflammatory mediators. Increased NF-κB activity has been associated with enhanced nociception and poorer recovery outcomes. Therefore, perioperative strategies that can reduce both pain and inflammatory response are of clinical importance.
Continuous erector spinae plane block (CESPB) is a regional anesthesia technique that provides multidermatomal analgesia by delivering local anesthetic into the fascial plane adjacent to the erector spinae muscle. Compared to single-shot techniques, CESPB using a catheter allows prolonged and stable analgesia. Ropivacaine is commonly used due to its favorable safety profile and potential anti-inflammatory effects.
This study is designed as a randomized controlled trial to compare CESPB using ropivacaine with standard analgesia without block in patients undergoing elective mastectomy. The primary outcome is postoperative pain intensity within 24 hours after surgery. Secondary outcomes include NF-κB levels, opioid consumption, incidence of postoperative nausea and vomiting, and quality of recovery measured using the QoR-15 questionnaire.
By integrating clinical and biomolecular outcomes, this study aims to provide comprehensive evidence regarding the effectiveness of CESPB not only in pain control but also in modulating the inflammatory response and improving postoperative recovery.
- Conditions
- Breast Cancer, Postoperative Pain, Acute
- Being tested
- Continuous Erector Spinae Plane Block, Ropivacaine
- Keywords
- Erector Spinae Plane Block, Continuous Erector Spinae Plane Block, Ropivacaine, Postoperative Pain, Mastectomy, Nuclear Factor Kappa B, Opioid Consumption, Quality of Recovery, Regional Anesthesia, Multimodal Analgesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
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
Ultrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia.
RopivacaineDrug
Local anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Erector Spinae Plane Block With Ropivacaine | Experimental | Participants will receive continuous erector spinae plane block using ropivacaine via catheter placement under ultrasound guidance, in addition to standard postoperative analgesia. Receives: Procedure: Continuous Erector Spinae Plane Block; Drug: Ropivacaine |
| Standard Analgesia Without Block | No intervention | Participants will receive standard postoperative analgesia according to institutional protocol, including oral paracetamol, intravenous ketorolac and opioid-based analgesia (patient-controlled analgesia with morphine), without erector spinae plane block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where higher scores indicate greater pain.
Measured: 24 hours after surgery
Secondary outcomes (4)
Change in Nuclear Factor Kappa B Levels From Baseline
Change in nuclear factor kappa B (NF-κB) levels from baseline to 24 hours after surgery, measured in blood samples to assess systemic inflammatory response.
Measured: Baseline and 24 hours after surgery
Opioid Consumption
Total opioid consumption within the first 24 hours after surgery, converted to morphine equivalent dose.
Measured: 24 hours after surgery
Quality of Recovery
Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, with higher scores indicating better recovery.
Measured: 24 hours after surgery
Postoperative Nausea and Vomiting
Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
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 Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive continuous erector spinae plane block with ropivacaine or standard analgesia without block in a parallel design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aldy Aldy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aldy Aldy, Udayana University
- Investigators
- Aldy Aldy, MD, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562945
- Sponsor's protocol ID
- CESPB-ALD-2026
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 May 2026
- 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 due to the presence of sensitive patient information and to ensure the confidentiality and privacy of research subjects in accordance with ethical guidelines.
Publications
Bajpai S, Kumar KS, Patibandla S, Giridhar CM. Ultrasound-guided continuous erector spinae plane block for perioperative opioid sparing analgesia in breast cancer surgery: A randomized controlled trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):327-333. doi: 10.4103/sja.sja_760_22. Epub 2023 Jun 22.
PubMed 37601522Forero 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 27501016Zhang X, Xiang GR, Wang ZX, Peng MQ, Li M. Effect of dexmedetomidine-ropivacaine transversus abdominis plane block on analgesia and cognitive impairment risk in colorectal cancer surgery. World J Gastrointest Surg. 2025 Jun 27;17(6):102907. doi: 10.4240/wjgs.v17.i6.102907.
PubMed 40584511
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Erector Spinae Plane Block With Ropivacaine Versus No Block on Postoperative Pain, NF-κB Levels, Opioid Consumption, and Quality of Recovery in Patients Undergoing Elective Mastectomy
- ClinicalTrials.gov ID
- NCT07562945
- Acronym / sponsor ID
- CESPB-ALD-2026
- Conditions
- Breast Cancer, Postoperative Pain, Acute
- Keywords
- Erector Spinae Plane Block, Continuous Erector Spinae Plane Block, Ropivacaine, Postoperative Pain, Mastectomy, Nuclear Factor Kappa B, Opioid Consumption, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aldy AldyUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 May 2026 (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.
This study aims to evaluate the effect of continuous erector spinae plane block (CESPB) using ropivacaine on postoperative pain in patients undergoing elective mastectomy. In addition to pain control, this study investigates the impact of CESPB on systemic inflammatory response as measured by nuclear factor kappa B (NF-κB) levels, opioid consumption, and quality of recovery. Patients will be randomly assigned to receive CESPB or standard analgesia without block. Outcomes will be assessed within the first 24 hours after surgery. The findings are expected to provide evidence on the clinical and biological benefits of CESPB as part of multimodal analgesia in breast surgery.
Detailed description
Breast cancer is one of the most common malignancies worldwide and frequently requires surgical management in the form of mastectomy. Postoperative pain following mastectomy remains a significant clinical problem, with a substantial proportion of patients experiencing moderate to severe pain. Inadequate pain control is associated with increased opioid consumption, delayed recovery, and a higher risk of developing chronic pain.
The inflammatory response plays an important role in postoperative pain, particularly through the activation of nuclear factor kappa B (NF-κB), a key transcription factor that regulates pro-inflammatory mediators. Increased NF-κB activity has been associated with enhanced nociception and poorer recovery outcomes. Therefore, perioperative strategies that can reduce both pain and inflammatory response are of clinical importance.
Continuous erector spinae plane block (CESPB) is a regional anesthesia technique that provides multidermatomal analgesia by delivering local anesthetic into the fascial plane adjacent to the erector spinae muscle. Compared to single-shot techniques, CESPB using a catheter allows prolonged and stable analgesia. Ropivacaine is commonly used due to its favorable safety profile and potential anti-inflammatory effects.
This study is designed as a randomized controlled trial to compare CESPB using ropivacaine with standard analgesia without block in patients undergoing elective mastectomy. The primary outcome is postoperative pain intensity within 24 hours after surgery. Secondary outcomes include NF-κB levels, opioid consumption, incidence of postoperative nausea and vomiting, and quality of recovery measured using the QoR-15 questionnaire.
By integrating clinical and biomolecular outcomes, this study aims to provide comprehensive evidence regarding the effectiveness of CESPB not only in pain control but also in modulating the inflammatory response and improving postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive continuous erector spinae plane block with ropivacaine or standard analgesia without block in a parallel design
| Arm | Type | Receives |
|---|---|---|
| Continuous Erector Spinae Plane Block With Ropivacaine | Experimental | Procedure: Continuous Erector Spinae Plane Block, Drug: RopivacaineParticipants will receive continuous erector spinae plane block using ropivacaine via catheter placement under ultrasound guidance, in addition to standard postoperative analgesia. |
| Standard Analgesia Without Block | No intervention | –Participants will receive standard postoperative analgesia according to institutional protocol, including oral paracetamol, intravenous ketorolac and opioid-based analgesia (patient-controlled analgesia with morphine), without erector spinae plane block. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18 to 65 years
- Diagnosed with breast cancer
- Scheduled for elective mastectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Able to understand and provide written informed consent
Key exclusion criteria (8 listed)
- Contraindications to regional anesthesia
- Contraindications or allergy to ropivacaine or local anesthetics
- Inability to use a visual analog scale (VAS) for pain assessment
- Inability to understand or operate patient-controlled analgesia (PCA)
- History of chronic pain or ongoing infection requiring treatment
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 BlockUltrasound-guided placement of a catheter in the erector spinae plane for continuous regional analgesia. | Procedure or surgery | Continuous Erector Spinae Plane Block With Ropivacaine |
| RopivacaineLocal anesthetic administered via continuous infusion through the erector spinae plane catheter for postoperative analgesia. | Drug | Continuous Erector Spinae Plane Block With Ropivacaine |
Primary outcome
Postoperative Pain Intensity
Time frame: 24 hours after surgery
Postoperative pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where higher scores indicate greater pain.
4 secondary outcomes
Change in Nuclear Factor Kappa B Levels From Baseline
Time frame: Baseline and 24 hours after surgery
Opioid Consumption
Time frame: 24 hours after surgery
Quality of Recovery
Time frame: 24 hours after surgery
Postoperative Nausea and Vomiting
Time frame: 24 hours after surgery
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 1 May 2026.
- Background: PubMed 37601522Bajpai S, Kumar KS, Patibandla S, Giridhar CM. Ultrasound-guided continuous erector spinae plane block for perioperative opioid sparing analgesia in breast cancer surgery: A randomized controlled trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):327-333. doi: 10.4103/sja.sja_760_22. Epub 2023 Jun 22.
- 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 40584511Zhang X, Xiang GR, Wang ZX, Peng MQ, Li M. Effect of dexmedetomidine-ropivacaine transversus abdominis plane block on analgesia and cognitive impairment risk in colorectal cancer surgery. World J Gastrointest Surg. 2025 Jun 27;17(6):102907. doi: 10.4240/wjgs.v17.i6.102907.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the presence of sensitive patient information and to ensure the confidentiality and privacy of research subjects in accordance with ethical guidelines.
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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.
Aldy Aldy, MD principal investigator
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Erector Spinae Plane Block and Ropivacaine in people with Breast Cancer and Postoperative Pain, Acute, run by Aldy Aldy 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 6 inclusion and 8 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 1 May 2026. 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.
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 Aldy Aldy, MD (+6285221222111, aldychen94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 24 hours after surgery). 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 NCT07562945, 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 1 May 2026.