Mammary CancerNCT06143020
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
A study testing Erector spinae plane block in people with Mammary Cancer and Erector Spinae Plane Block, run by Fudan University at 1 site in China.
Trial summary
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Mammary Cancer, Erector Spinae Plane Block, Postoperative Pain
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 25 Aug 2025
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for an radical mastectomy and implant reconstruction surgery
- Patients with American Society of Anesthesiologists (ASA) physical status I-II,
- aged 18-70 years
Who cannot join
- coagulation disorders,
- known allergy to study drugs,
- obesity (body mass index > 35 kg/m2),
- infection at the injection site,
- chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
- patient refuse
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.
Read the detailed description
Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT
- Being tested
- Erector spinae plane block
- Keywords
- Mammary Cancer, implant reconstruction, erector spinae plane block, Postoperative Pain
- 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.
Erector spinae plane blockProcedure or surgery
Also called Ultrasound-guided erector spinae plane block
In the ESPB group, the patients were placed in the lateral decubitus position. The ultrasound probe was located in longitudinal orientation at the level of the T4 spinous process and then placed 3 cm laterally from the midline to the side involved in the surgery. The ultrasound landmarks, T4 transverse process, and the overlying trapezius, rhomboideus, and erector spinae muscles, were identified. Under aseptic conditions, an 80-mm 21-gauge block needle was inserted in-plane at an angle of 30-40° in the cranial-to-caudal direction until the tip contacted the T4 transverse process.After the hydrodissection with 2-3 mL of isotonic saline solution confirmed the correct needle tip position, the intermixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle. Local anesthetic spread in a fascial longitudinal pattern deep to the erector spinae muscle was visualized using ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Experimental | Before surgery, an ultrasound-guided ESPB was performed. 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle.
Ropivacaine is produced by AstraZeneca AB under the trade name of Naropin, and the specifications are 75 mg / 10 ml. Dexmedetomidine is produced by HengRui medical China and the specifications are 100μg / 1 ml。 Receives: Procedure: Erector spinae plane block |
| Control group | No intervention | Control groups do not receive additional analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative acute pain score at 6 hours
11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery
Measured: 6 hours After surgery
Secondary outcomes (4)
Postoperative quality of recovery score
The QoR-15 will be used to evaluate postoperative quality of recovery from 15 dimensions. The QoR-15 scale is a global measurement of postoperative recovery, consisting of 15 items with 10 points each, with a total score ranging from 0 (QoR very poor) to 150 (QoR very good).
Measured: 24 to 72 hours after the surgery
Post-operative acute pain score
Pain scores at other time points except for the primary outcome. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
Measured: 1h, 12h,24, 48h, 72h after the surgery, separately.
Cumulative opioid consumption after surgery
Cumulative opioid consumption after surgery
Measured: 48 hours after the surgery
AUC of postoperative pain score
Area under the curve(AUC) of pain score 72 hours after surgery
Measured: 72 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start20 Nov 2023
- Primary completion20 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mammary CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143020
- Sponsor's protocol ID
- ESPB of BCIR 2.0
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ling D, Wei S, He Q, Li Y, Xu Q, Jiao W, Zhang J. Effects of erector spinae plane block on postoperative pain in patients undergoing implant-based breast reconstruction for breast cancer: a randomized controlled trial. Ann Med. 2026 Dec;58(1):2722439. doi: 10.1080/07853890.2026.2722439. Epub 2026 Sep 2.
PubMed 42686359
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
- ClinicalTrials.gov ID
- NCT06143020
- Acronym / sponsor ID
- ESPB of BCIR 2.0
- Keywords
- Mammary Cancer, implant reconstruction, erector spinae plane block, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 22 Nov 2023 (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.
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.
Detailed description
Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group | Experimental | Procedure: Erector spinae plane blockBefore surgery, an ultrasound-guided ESPB was performed. 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle. Ropivacaine is produced by AstraZeneca AB under the trade name of Naropin, and the specifications are 75 mg / 10 ml. Dexmedetomidine is produced by HengRui medical China and the specifications are 100μg / 1 ml。 |
| Control group | No intervention | –Control groups do not receive additional analgesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for an radical mastectomy and implant reconstruction surgery
- Patients with American Society of Anesthesiologists (ASA) physical status I-II,
- aged 18-70 years
Key exclusion criteria (6 listed)
- coagulation disorders,
- known allergy to study drugs,
- obesity (body mass index > 35 kg/m2),
- infection at the injection site,
- chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
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 blockAlso: Ultrasound-guided erector spinae plane blockIn the ESPB group, the patients were placed in the lateral decubitus position. The ultrasound probe was located in longitudinal orientation at the level of the T4 spinous process and then placed 3 cm laterally from the midline to the side involved in the surgery. The ultrasound landmarks, T4 transverse process, and the overlying trapezius, rhomboideus, and erector spinae muscles, were identified. Under aseptic conditions, an 80-mm 21-gauge block needle was inserted in-plane at an angle of 30-40° in the cranial-to-caudal direction until the tip contacted the T4 transverse process.After the hydrodissection with 2-3 mL of isotonic saline solution confirmed the correct needle tip position, the intermixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle. Local anesthetic spread in a fascial longitudinal pattern deep to the erector spinae muscle was visualized using ultrasound guidance. | Procedure or surgery | Erector spinae plane block group |
Primary outcome
Post-operative acute pain score at 6 hours
Time frame: 6 hours After surgery
11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery
4 secondary outcomes
Postoperative quality of recovery score
Time frame: 24 to 72 hours after the surgery
Post-operative acute pain score
Time frame: 1h, 12h,24, 48h, 72h after the surgery, separately.
Cumulative opioid consumption after surgery
Time frame: 48 hours after the surgery
AUC of postoperative pain score
Time frame: 72 hours after the surgery
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 17 Nov 2025.
- Derived from this study: PubMed 42686359Ling D, Wei S, He Q, Li Y, Xu Q, Jiao W, Zhang J. Effects of erector spinae plane block on postoperative pain in patients undergoing implant-based breast reconstruction for breast cancer: a randomized controlled trial. Ann Med. 2026 Dec;58(1):2722439. doi: 10.1080/07853890.2026.2722439. Epub 2026 Sep 2.
- Individual participant dataSharing planned: No
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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.
Jun Zhang, PhD principal investigator
Fudan 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 Erector spinae plane block in people with Mammary Cancer and Erector Spinae Plane Block, run by Fudan University at 1 site in China.
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 17 Nov 2025. 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 China. 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?
Post-operative acute pain score at 6 hours (time frame: 6 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 NCT06143020, which also lists 1 linked publication.
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 17 Nov 2025.