Breast CancerNCT05266378
Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients
A study testing PECs block and Not receiving PECs Block in people with Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PECs block and Not receiving PECs Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2022to 24 Mar 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years who underwent partial mastectomy for breast cancer.
Who cannot join
- Patients with a history of previous breast surgery
- Patients with a history of adverse reactions to local anesthetics
- Patients with a history of drug addiction
- Patients with cancer other than breast
- Patients with chronic pain who require analgesics
- History of hospitalization for psychiatric disorders
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- Preoperative pulse oximetry (SpO2) < 95 %
- Left ventricular ejection fraction < 40%
- Moderate or severe hepatic impairment
- Body mass index over 35 kg/m2
- Blood clotting disorders
- Pregnant/lactating women
- Inability to understand consent forms and answer research questionnaires due to cognitive impairment
- Unable to read consent form (eg illiterate, foreigner, etc.)
- do not perform axillary lymph node dissection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Young Song
Seoul
Young Song, 82-2-2019-6629, gsirb@yuhs.ac
About this study
Official title: The Effect of Pectoralis Nerve Block on Quality of Recovery in Patients Undergoing Breast-conservative Surgery
Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block.
This study aims to assess effect of pectoralis nerve block on QoR-15 score in subgroups stratified by such factors.
Read the detailed description
Study population All of patients will undergo partial mastectomy. 140 patients will be enrolled.
Intervention Pectoralis nerve block will be performed in the Block group.
Psychosocial factor screening Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)
Study endpoints Quality of recovery (QoR)-15 Pain visual analogue scale Opioid consumption Breast Cancer Pain Questionnaire (BCPQ)
- Conditions
- Breast Cancer
- Being tested
- PECs block, Not receiving PECs Block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECs blockProcedure or surgery
The PECs block is performed immediately after induction of anesthesia, and 0.375% concentration of ropivacaine (carbiropivacaine injection, Fresinius Kavi Korea Co., Ltd.) is used with a 25 G 5 cm (or 8 cm) needle to induce ultrasound-guided pectoralis major (pectoralis major). 10mL (PECs I block) into the fascia between the pectoralis minor muscle) and the pectoralis minor muscle, and 20mL (PECs II block) between the pectoralis minor and serratus anterior muscle.
Not receiving PECs BlockOther
In this group, the PECs block was not implemented.
| Study group | Role | What they receive |
|---|---|---|
| Block group | Experimental | The group undergoing PECs block Receives: Procedure: PECs block |
| Control group | Placebo comparator | The group not receiving PECs block Receives: Other: Not receiving PECs Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15
To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery.
Measured: Postoperative day 1
Secondary outcomes (1)
Intensity of pain
Intensity of pain will be recorded by using VAS (0-10).
Measured: Postoperative day 0, 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start23 Feb 2022
- Primary completion23 Feb 2024 (estimated)
- Study completion24 Mar 2025 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Control arm: Conventional Anesthesia 2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266378
- Sponsor's protocol ID
- 3-2021-0468
- Status last verified
- Jan 2023
- First submitted
- 23 Feb 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.
PubMed 33492696
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pectoralis Nerve Block on Quality of Recovery in Patients Undergoing Breast-conservative Surgery
- ClinicalTrials.gov ID
- NCT05266378
- Acronym / sponsor ID
- 3-2021-0468
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 23 Feb 2024 (estimated)
- Study completion
- 24 Mar 2025 (estimated)
- First posted
- 4 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.
Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block.
This study aims to assess effect of pectoralis nerve block on QoR-15 score in subgroups stratified by such factors.
Detailed description
Study population All of patients will undergo partial mastectomy. 140 patients will be enrolled.
Intervention Pectoralis nerve block will be performed in the Block group.
Psychosocial factor screening Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)
Study endpoints Quality of recovery (QoR)-15 Pain visual analogue scale Opioid consumption Breast Cancer Pain Questionnaire (BCPQ)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Control arm: Conventional Anesthesia 2. Interventional arm: Conventional Anesthesia with pectoralis nerve block.
| Arm | Type | Receives |
|---|---|---|
| Block group | Experimental | Procedure: PECs blockThe group undergoing PECs block |
| Control group | Placebo comparator | Other: Not receiving PECs BlockThe group not receiving PECs block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20 to 80 years who underwent partial mastectomy for breast cancer.
Key exclusion criteria (15 listed)
- Patients with a history of previous breast surgery
- Patients with a history of adverse reactions to local anesthetics
- Patients with a history of drug addiction
- Patients with cancer other than breast
- Patients with chronic pain who require analgesics
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 |
|---|---|---|
| PECs blockThe PECs block is performed immediately after induction of anesthesia, and 0.375% concentration of ropivacaine (carbiropivacaine injection, Fresinius Kavi Korea Co., Ltd.) is used with a 25 G 5 cm (or 8 cm) needle to induce ultrasound-guided pectoralis major (pectoralis major). 10mL (PECs I block) into the fascia between the pectoralis minor muscle) and the pectoralis minor muscle, and 20mL (PECs II block) between the pectoralis minor and serratus anterior muscle. | Procedure or surgery | Block group |
| Not receiving PECs BlockIn this group, the PECs block was not implemented. | Other | Control group |
Primary outcome
QoR-15
Time frame: Postoperative day 1
To compare the difference in the quality of recovery between groups, the QoR-15 questionnaire is administered on the 1st day after surgery.
1 secondary outcome
Intensity of pain
Time frame: Postoperative day 0, 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 33492696Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECs block and Not receiving PECs Block in people with Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Jan 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Song (82-2-2019-6692, nearmyheart@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 (time frame: Postoperative day 1). 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 NCT05266378, 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 20 Jan 2023.