Breast Cancer FemalePNBNCT05699902
Pectoral Nerve Block During Mastectomy
A study testing PECs block during mastectomy in people with Breast Cancer Female and Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Pain, Postoperative
- What is being tested?
- PECs block during mastectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Dec 2024
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1- all female planed for elective breast surgery
Who cannot join
- Planned for bilateral axillary or bilateral reconstruction surgery.
- Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
- Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
- known contraindications to peripheral nerve block placement.
- Pregnant or breastfeeding.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition
- Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy
Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study
Read the detailed description
Breast cancer is the most common malignancy in women; surgery is still the mainstay for the treatment of breast cancer .
Postoperative pain can seriously reduce the quality of patient's life, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during mastectomy, but their applications are limited by the complicated technique of the procedures and several complications.
In recent years, there has been increasing interest on a novel, less invasive technique, the pectoral nerve (PECS) block. Numerous clinical trials have focused on the analgesic potential of the pectoral nerve block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results.
Several prospective observational studies in recent years demonstrated that postoperative pain following breast surgery becomes chronic in up to 57% of women.
One of the most important risk factors is insufficiently treated postoperative acute pain. The current gold standard for acute postoperative pain is a preventive procedure-specific multimodal treatment including nonopioids, opioids and regional analgesia.
A recently published Cochran's meta-analysis demonstrated that regional analgesia [e.g. paravertebral block (PVB), local infiltration] might even reduce the risk of chronic postsurgical pain after breast surgery. According to a recently published guidelines, pectoral nerves (PECS) blocks seem to be an effective alternative to PVB to manage effectively postsurgical pain in major breast surgery.Anatomical studies revealed a different local anaesthetic spread following injections between the pectoralis major and minor muscles (PECS I) and a combination of the latter injection with a deeper injection between the pectoralis minor and serratus anterior muscles (PECS II) but the results were not conclusive. Many trials have been published and some meta-analyses revealed a high analgesic efficacy following PECS II blocks compared with no block or PVB.
However, one of these meta-analyses was criticised because of methodological problems (e.g. evidence assessment, missing sham block group), pain intensities not analysed separately for resting pain and pain during movement and comparisons with other established or emerging regional anaesthetic techniques (e.g. local infiltration, erector spinae block) were not performed.
- Conditions
- Breast Cancer Female, Pain, Postoperative
- Being tested
- PECs block during mastectomy, Sham block
- Keywords
- Breast cancer, Pain after mastectomy, PECs block
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECs block during mastectomyProcedure or surgery
Also called PECs nerve injection
The patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. MAIN OUTCOME MEASURES
Sham blockProcedure or surgery
Also called Non PECs block
Female undergone mastectomy and have received conventional analgesic methods
| Study group | Role | What they receive |
|---|---|---|
| PECs block group | Active comparator | Female undergone mastectomy and received pectoral nerve block Receives: Procedure: PECs block during mastectomy |
| Non PECs block group | Sham comparator | Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods Receives: Procedure: Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
Measured: 1year
Secondary outcomes (1)
Patient's quality of life
- Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
- Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- Interventional
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Salah Abd-Ellah, Assiut University
- Investigators
- Mostafa Alaa eldin, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699902
- Sponsor's protocol ID
- Pectoral nerve block in breast
- Acronym
- PNB
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available when the targeted number of cases reached
Publications
Ueshima H, Otake H, Hara E, Blanco R. How to Use Pectoral Nerve Blocks Effectively-An Evidence-Based Update. Asian J Anesthesiol. 2019 Jun 1;57(2):28-36. doi: 10.6859/aja.201906_57(2).0002.
PubMed 31382323Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
PubMed 34195767Daniel Pereira D, Bleeker H, Malic C, Barrowman N, Shadrina A. Pectoral nerve block and acute pain management after breast reduction surgery in adolescent patients. Can J Anaesth. 2021 Oct;68(10):1574-1575. doi: 10.1007/s12630-021-02037-8. Epub 2021 Jun 3. No abstract available.
PubMed 34081262
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy
- ClinicalTrials.gov ID
- NCT05699902
- Acronym / sponsor ID
- PNB / Pectoral nerve block in breast
- Conditions
- Breast Cancer Female, Pain, Postoperative
- Keywords
- Breast cancer, Pain after mastectomy, PECs block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Jan 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.
Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study
Detailed description
Breast cancer is the most common malignancy in women; surgery is still the mainstay for the treatment of breast cancer .
Postoperative pain can seriously reduce the quality of patient's life, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during mastectomy, but their applications are limited by the complicated technique of the procedures and several complications.
In recent years, there has been increasing interest on a novel, less invasive technique, the pectoral nerve (PECS) block. Numerous clinical trials have focused on the analgesic potential of the pectoral nerve block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results.
Several prospective observational studies in recent years demonstrated that postoperative pain following breast surgery becomes chronic in up to 57% of women.
One of the most important risk factors is insufficiently treated postoperative acute pain. The current gold standard for acute postoperative pain is a preventive procedure-specific multimodal treatment including nonopioids, opioids and regional analgesia.
A recently published Cochran's meta-analysis demonstrated that regional analgesia [e.g. paravertebral block (PVB), local infiltration] might even reduce the risk of chronic postsurgical pain after breast surgery. According to a recently published guidelines, pectoral nerves (PECS) blocks seem to be an effective alternative to PVB to manage effectively postsurgical pain in major breast surgery.Anatomical studies revealed a different local anaesthetic spread following injections between the pectoralis major and minor muscles (PECS I) and a combination of the latter injection with a deeper injection between the pectoralis minor and serratus anterior muscles (PECS II) but the results were not conclusive. Many trials have been published and some meta-analyses revealed a high analgesic efficacy following PECS II blocks compared with no block or PVB.
However, one of these meta-analyses was criticised because of methodological problems (e.g. evidence assessment, missing sham block group), pain intensities not analysed separately for resting pain and pain during movement and comparisons with other established or emerging regional anaesthetic techniques (e.g. local infiltration, erector spinae block) were not performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| PECs block group | Active comparator | Procedure: PECs block during mastectomyFemale undergone mastectomy and received pectoral nerve block |
| Non PECs block group | Sham comparator | Procedure: Sham blockFemale undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- all female planed for elective breast surgery
Key exclusion criteria (7 listed)
- Planned for bilateral axillary or bilateral reconstruction surgery.
- Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
- known contraindications to peripheral nerve block placement.
- Pregnant or breastfeeding.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition
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 block during mastectomyAlso: PECs nerve injectionThe patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. MAIN OUTCOME MEASURES | Procedure or surgery | PECs block group |
| Sham blockAlso: Non PECs blockFemale undergone mastectomy and have received conventional analgesic methods | Procedure or surgery | Non PECs block group |
Primary outcome
Post operative pain
Time frame: 1year
Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).
1 secondary outcome
Patient's quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 31382323Ueshima H, Otake H, Hara E, Blanco R. How to Use Pectoral Nerve Blocks Effectively-An Evidence-Based Update. Asian J Anesthesiol. 2019 Jun 1;57(2):28-36. doi: 10.6859/aja.201906_57(2).0002.
- Background: PubMed 34195767Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
- Background: PubMed 34081262Daniel Pereira D, Bleeker H, Malic C, Barrowman N, Shadrina A. Pectoral nerve block and acute pain management after breast reduction surgery in adolescent patients. Can J Anaesth. 2021 Oct;68(10):1574-1575. doi: 10.1007/s12630-021-02037-8. Epub 2021 Jun 3. No abstract available.
- Individual participant dataSharing planned: Yes. The study will be available when the targeted number of cases reached
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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.
Mostafa Alaa eldin, Prof study director
Assiut 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 PECs block during mastectomy in people with Breast Cancer Female and Pain, Postoperative, run by Assiut University at 1 site in Egypt.
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 7 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 26 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 Egypt. 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 Khaled Salah, Resident Dr (+201030026633 ext. +2, ksa53516@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 1year). 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 NCT05699902, 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 26 Jan 2023.