Breast CancerNCT05448638
Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery
A study testing the combination of transversus thoracic muscle plane and pectoral nerves blocks and the pectoral nerves block only in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- the combination of transversus thoracic muscle plane and pectoral nerves blocks and the pectoral nerves block only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2022to 5 Aug 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female, 18-80 years of age
- American Society of Anesthesiologists physical status I-III
- patients having elective unilateral breast cancer surgery
Who cannot join
- contraindication to nerve block
- inability to understand or communicate with research personnel
- chronic use of opioids or nonsteroidal anti-inflammatory drugs
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial
This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.
Read the detailed description
The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.
- Conditions
- Breast Cancer
- Being tested
- the combination of transversus thoracic muscle plane and pectoral nerves blocks, the pectoral nerves block only
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the combination of transversus thoracic muscle plane and pectoral nerves blocksProcedure or surgery
For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. For the transversus thoracic muscle plane block, ropivacaine 0.375%,15ml was injected between the transversus thoracic muscle and the internal intercostal muscle.
the pectoral nerves block onlyProcedure or surgery
For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle.
| Study group | Role | What they receive |
|---|---|---|
| transversus thoracic muscle plane block+pectoral nerves block | Experimental | the combination of transversus thoracic muscle plane and pectoral nerves blocks Receives: Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks |
| pectoral nerves block | Active comparator | the pectoral nerves block only Receives: Procedure: the pectoral nerves block only |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of recovery-15 questionnaire (QoR-15)
The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery.
- Able to breathe easily
- Been able to enjoy food
- Feeling rested
- Have had a good sleep
- Able to look after personal toilet and hygiene unaided
- Able to communicate with family or friends
- Getting support from hospital doctors and nurses
- Able to return to work or usual home activities
- Feeling comfortable and in control
- Having a feeling of general well-being
- Moderate pain
- Severe pain
- Nausea or vomiting
- Feeling worried or anxious
- Feeling sad or depressed
Measured: at 24 hours after surgery
Secondary outcomes (11)
NRS score for rest and coughing pain
Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
Measured: at 1, 6, 24, 48 hours after surgery
consumption of opioid converted to IV morphine equivalents
opioids given postoperatively converted to IV morphine equivalents
Measured: during 24 hours after surgery
the incidence of postoperative hypotension
Adverse reactions related to opioid
Measured: during 48 hours after surgery
the incidence of nausea and vomiting
Adverse reactions related to opioid
Measured: during 48 hours after surgery
the incidence of pruritus
Adverse reactions related to opioid
Measured: during 48 hours after surgery
the incidence of respiratory depression
Adverse reactions related to opioid
Measured: during 48 hours after surgery
time to urethral catheter removal in hours
Time tourethral catheter removal after surgery
Measured: through study completion, an average of 24-36 hours
postoperative hospital stay in days
The time from operation to discharge
Measured: through study completion, an average of 5-7 days
intra-operative opioid requirements
opioids given intra-operatively
Measured: through the anesthesia process, an average of 1.5-2.5h
the block-related outcomes
the incidence of block-related complications (accidental intravascular injection, local anaesthetic systemic toxicity, haematoma and pneumothorax); and incidence of patient-reported transient neurological complications (paraesthesia or sensory deficit)
Measured: through study completion, an average of 5-7 days
the Brief Pain Inventory
The Brief Pain Inventory instrument assesses 2 domains: pain and pain-related interference with physical and emotional functioning.
- pain at its worst in the last 24 hours
- pain at least in the last 24 hours
- describe your pain on average
- how much pain do you have right now
- interference with general activity
- interference with working ability
- interference with work
- interference with mood
- interference with relations with other people
- interference with sleep
- interference with enjoyment of life
Measured: at 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start12 Jul 2022
- Primary completion5 May 2023
- Study completion5 Aug 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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huifang Jiang, Zhejiang Cancer Hospital
- Investigators
- Huifang Jiang, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448638
- Sponsor's protocol ID
- IRB-2022-348
- Status last verified
- Nov 2023
- First submitted
- 3 Jul 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.
PubMed 39453840
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05448638
- Acronym / sponsor ID
- IRB-2022-348
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 7 Jul 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.
This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.
Detailed description
The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus thoracic muscle plane block+pectoral nerves block | Experimental | Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocksthe combination of transversus thoracic muscle plane and pectoral nerves blocks |
| pectoral nerves block | Active comparator | Procedure: the pectoral nerves block onlythe pectoral nerves block only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female, 18-80 years of age
- American Society of Anesthesiologists physical status I-III
- patients having elective unilateral breast cancer surgery
Key exclusion criteria (4 listed)
- contraindication to nerve block
- inability to understand or communicate with research personnel
- chronic use of opioids or nonsteroidal anti-inflammatory drugs
- pregnancy
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 |
|---|---|---|
| the combination of transversus thoracic muscle plane and pectoral nerves blocksFor the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. For the transversus thoracic muscle plane block, ropivacaine 0.375%,15ml was injected between the transversus thoracic muscle and the internal intercostal muscle. | Procedure or surgery | transversus thoracic muscle plane block+pectoral nerves block |
| the pectoral nerves block onlyFor the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. | Procedure or surgery | pectoral nerves block |
Primary outcome
the quality of recovery-15 questionnaire (QoR-15)
Time frame: at 24 hours after surgery
The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery. 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with family or friends 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed
11 secondary outcomes
NRS score for rest and coughing pain
Time frame: at 1, 6, 24, 48 hours after surgery
consumption of opioid converted to IV morphine equivalents
Time frame: during 24 hours after surgery
the incidence of postoperative hypotension
Time frame: during 48 hours after surgery
the incidence of nausea and vomiting
Time frame: during 48 hours after surgery
the incidence of pruritus
Time frame: during 48 hours after surgery
the incidence of respiratory depression
Time frame: during 48 hours after surgery
time to urethral catheter removal in hours
Time frame: through study completion, an average of 24-36 hours
postoperative hospital stay in days
Time frame: through study completion, an average of 5-7 days
intra-operative opioid requirements
Time frame: through the anesthesia process, an average of 1.5-2.5h
the block-related outcomes
Time frame: through study completion, an average of 5-7 days
the Brief Pain Inventory
Time frame: at 3 months after 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 21 Nov 2023.
- Derived from this study: PubMed 39453840Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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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.
Huifang Jiang, MD principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the combination of transversus thoracic muscle plane and pectoral nerves blocks and the pectoral nerves block only in people with Breast Cancer, run by Zhejiang Cancer Hospital 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 4 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 21 Nov 2023. 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?
the quality of recovery-15 questionnaire (QoR-15) (time frame: at 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 NCT05448638, 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 21 Nov 2023.