Mammary CancerNCT05299021
Serratus Anterior Plane Block for Modified Radical Mastectomy: Double-point VS Single-point
A study testing Double-point SAPB and Single-point SAPB in people with Mammary Cancer and Serratus Anterior 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. As is known to all, less postoperative complications and enhanced recovery are closely related to effective analgesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Mammary Cancer, Serratus Anterior Plane Block, Postoperative Pain
- What is being tested?
- Double-point SAPB and Single-point SAPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 8 Dec 2023
- 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 are proposed to undergo Modified Radical Mastectomy
- Patients with American Society of Anesthesiologists (ASA) physical status I~III
- aged 18-70 years
- BMI ≤ 35 kg/m2
Who cannot join
- Patients with a pre-existing neuropathy or sensory deficit affecting the operative region
- Pregnancy
- Chronic pain or opioid dependence (at least 30 mg of oxycodone or equivalent per day)
- Allergy to local anaesthesia or any component of the proposed multimodal analgesia regimen
- Local or systemic contra-indications to peripheral nerve blocks (local infection at the puncture site, coagulopathy, platelets less than 80*10^9/L and prothrombin time more than 15 s)
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: The Analgesic Effect of Ultrasound-guided Double-point Versus Single-point Serratus Anterior Plane Block on Modified Radical Mastectomy：A Randomized Controlled Study
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery. As is known to all, less postoperative complications and enhanced recovery are closely related to effective analgesia. However, postoperative patients often experience moderate pain, while associated with axillary discomfort. Serratus Anterior Plane Block (SAPB) relieves postoperative pain, but traditional single point block method has no effect on axillary discomfort. Therefore, it is necessary to try double point blocks to explore their impact on postoperative analgesia and axillary comfort. This RCT will recruit patients proposed to undergo Modified Radical Mastectomy (MRM) and be randomized to single point or double point groups to evaluate their postoperative pain score and axillary comfort in order to provide clinical guidance.
Read the detailed description
The conventional SAPB, which often performs single point block from the level of the fifth rib, does not completely relieve postoperative pain in patients with axillary lymph node dissection, probably due to insufficient range of local anesthetic diffusion.Anatomical study indicated that with a double point SAPB at the third and fifth rib levels, respectively, the local anesthetic diffusion range can reach the axillary level and may provide better analgesic effects. However, the support of clinical data is lacking.Therefore, the hypothesis of this study is that double point SAPB will provide better postoperative analgesia compared with conventional single point SAPB in patients undergoing modified radical mastectomy.This study will include 60 patients proposed to undergo modified radical mastectomy, allocated to the Double-point or Single-point group in a 1:1 ratio, randomly.The Double-point group will perform a double point SAPB, which is a combined block at the third and fifth rib levels, respectively.The Single-point group will undergo a single point SAPB, traditionally performed at the level of the fifth rib.Observation outcomes included changes in blood pressure and heart rate during dissection of skin and dissection of axillary lymph nodes, postoperative pain scores, axillary comfort, recovery quality, and related complications and postoperative hospital stay.Therefore, the objective is to investigate whether this simple technical modification can better reduce postoperative pain and promote rehabilitation in patients with modified radical mastectomy.
- Being tested
- Double-point SAPB, Single-point SAPB
- Keywords
- Mammary Cancer, Serratus Anterior Plane Block, Postoperative Pain, Axillary Discomfort
- 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.
Double-point SAPBProcedure or surgery
A high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration. And use the same method targeting the plane between the serratus anterior muscle and the third rib.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5 μ g/kg dexmedetomidine mixture will be injected into the two points with 15 ml separately.
Single-point SAPBProcedure or surgery
A high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Double-point SAPB | Experimental | SAPB will be performed simultaneously in both the third and fifth rib levels. Receives: Procedure: Double-point SAPB |
| Single-point SAPB | Experimental | SAPB will be performed only in the fifth rib level. Receives: Procedure: Single-point SAPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain severity at 24 h
Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. 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". 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.
Measured: 24 hours after the surgery
Secondary outcomes (3)
Pain severity at discharge from PACU and at 6 and 12 and 48 h postoperatively
Secondary analgesic outcomes included: pain severity at rest and movement measured using a NRS at discharge from PACU and at 6 and 12 and 48 h postoperatively;
Measured: Respectively at discharge from PACU and at 6 and 12 and 48 h after the surgery;
Postoperative opioid consumption
At the end of surgery, patients use postoperative controlled analgesia pump, equip with 0.75 μg / ml sufentanil without background dose, locking time is 10min, and each controlled dose is 2 ml. The cumulative amount of sufentanil used at 24 and 48 hours after surgery will be recorded separately.
Measured: Respectively at 24 and 48 h after the surgery;
Proportion of rescue analgesia
Rescue analgesia was started when NRS ≥ 4, with Flurbiprofen Axetil 50mg i. v. The proportion of patients who required at least one rescue analgesia at 48 hours after surgery will be recorded.
Measured: 48 h 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 posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion5 Dec 2023
- Study completion8 Dec 2023
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
- Investigator, Outcomes assessor
- Enrolment
- 57 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
- NCT05299021
- Sponsor's protocol ID
- SAPB for MRM 2.0
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Ling D, Xu Q, Sun P, Wei S, Gao L, Lou F, Zhang J. Ultrasound-Guided Double-Point Versus Single-Point Serratus Anterior Plane Block for Modified Radical Mastectomy: A Randomized Controlled Trial. Clin J Pain. 2025 Jan 1;41(1):e1256. doi: 10.1097/AJP.0000000000001256.
PubMed 39475834
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Ultrasound-guided Double-point Versus Single-point Serratus Anterior Plane Block on Modified Radical Mastectomy：A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05299021
- Acronym / sponsor ID
- SAPB for MRM 2.0
- Keywords
- Mammary Cancer, Serratus Anterior Plane Block, Postoperative Pain, Axillary Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 28 Mar 2022 (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. As is known to all, less postoperative complications and enhanced recovery are closely related to effective analgesia. However, postoperative patients often experience moderate pain, while associated with axillary discomfort. Serratus Anterior Plane Block (SAPB) relieves postoperative pain, but traditional single point block method has no effect on axillary discomfort. Therefore, it is necessary to try double point blocks to explore their impact on postoperative analgesia and axillary comfort. This RCT will recruit patients proposed to undergo Modified Radical Mastectomy (MRM) and be randomized to single point or double point groups to evaluate their postoperative pain score and axillary comfort in order to provide clinical guidance.
Detailed description
The conventional SAPB, which often performs single point block from the level of the fifth rib, does not completely relieve postoperative pain in patients with axillary lymph node dissection, probably due to insufficient range of local anesthetic diffusion.Anatomical study indicated that with a double point SAPB at the third and fifth rib levels, respectively, the local anesthetic diffusion range can reach the axillary level and may provide better analgesic effects. However, the support of clinical data is lacking.Therefore, the hypothesis of this study is that double point SAPB will provide better postoperative analgesia compared with conventional single point SAPB in patients undergoing modified radical mastectomy.This study will include 60 patients proposed to undergo modified radical mastectomy, allocated to the Double-point or Single-point group in a 1:1 ratio, randomly.The Double-point group will perform a double point SAPB, which is a combined block at the third and fifth rib levels, respectively.The Single-point group will undergo a single point SAPB, traditionally performed at the level of the fifth rib.Observation outcomes included changes in blood pressure and heart rate during dissection of skin and dissection of axillary lymph nodes, postoperative pain scores, axillary comfort, recovery quality, and related complications and postoperative hospital stay.Therefore, the objective is to investigate whether this simple technical modification can better reduce postoperative pain and promote rehabilitation in patients with modified radical mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-point SAPB | Experimental | Procedure: Double-point SAPBSAPB will be performed simultaneously in both the third and fifth rib levels. |
| Single-point SAPB | Experimental | Procedure: Single-point SAPBSAPB will be performed only in the fifth rib level. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are proposed to undergo Modified Radical Mastectomy
- Patients with American Society of Anesthesiologists (ASA) physical status I~III
- aged 18-70 years
- BMI ≤ 35 kg/m2
Key exclusion criteria (5 listed)
- Patients with a pre-existing neuropathy or sensory deficit affecting the operative region
- Pregnancy
- Chronic pain or opioid dependence (at least 30 mg of oxycodone or equivalent per day)
- Allergy to local anaesthesia or any component of the proposed multimodal analgesia regimen
- Local or systemic contra-indications to peripheral nerve blocks (local infection at the puncture site, coagulopathy, platelets less than 80*10^9/L and prothrombin time more than 15 s)
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 |
|---|---|---|
| Double-point SAPBA high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration. And use the same method targeting the plane between the serratus anterior muscle and the third rib.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5 μ g/kg dexmedetomidine mixture will be injected into the two points with 15 ml separately. | Procedure or surgery | Double-point SAPB |
| Single-point SAPBA high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture will be injected. | Procedure or surgery | Single-point SAPB |
Primary outcome
Postoperative pain severity at 24 h
Time frame: 24 hours after the surgery
Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. 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". 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.
3 secondary outcomes
Pain severity at discharge from PACU and at 6 and 12 and 48 h postoperatively
Time frame: Respectively at discharge from PACU and at 6 and 12 and 48 h after the surgery;
Postoperative opioid consumption
Time frame: Respectively at 24 and 48 h after the surgery;
Proportion of rescue analgesia
Time frame: 48 h 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 6 Mar 2024.
- Derived from this study: PubMed 39475834Xu J, Ling D, Xu Q, Sun P, Wei S, Gao L, Lou F, Zhang J. Ultrasound-Guided Double-Point Versus Single-Point Serratus Anterior Plane Block for Modified Radical Mastectomy: A Randomized Controlled Trial. Clin J Pain. 2025 Jan 1;41(1):e1256. doi: 10.1097/AJP.0000000000001256.
- 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 Double-point SAPB and Single-point SAPB in people with Mammary Cancer and Serratus Anterior 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 4 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: finished, as of the sponsor's last update on 6 Mar 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 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?
Postoperative pain severity at 24 h (time frame: 24 hours after the 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 NCT05299021, 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 6 Mar 2024.