Persistent Pain After Breast Cancer SurgeryPhase 2PPBCSNCT02349581
Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery
A Phase 2 study testing PECS block and Bupivacaine in people with Persistent Pain After Breast Cancer Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Persistent Pain After Breast Cancer Surgery
- What is being tested?
- PECS block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients, aged 18 years or over, treated for breast cancer
- Patients with persistent pain in the breast after surgical treatment for breast cancer. Their pain score must be 4 or more on the numerical rating scale (NRS).
Who cannot join
- breast surgery within the last 12 months
- previous cosmetic surgery
- bilateral breast cancer (receiving bilateral intervention)
- pregnant or breast feeding
- neurological disease
- on-going treatment for severe mental illness or who abuse alcohol or drugs
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- are unable to understand written or spoken Danish or English
- lack mental capacity to give informed consent or cooperate with the neurophysiological testing
- an allergy to amide local anaesthetics
- pacemaker in situ
- received treatment outside guidelines and recommendations from the Danish Breast Cancer Co-operative Group (DBCG)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Section for surgical pathophysiology 7621 Rigshospitalet
Copenhagen, Region Sjælland, 2100
Nelun Wijayasinghe, MBBS, BSc, +45 35456643, nelun.wijayasinghe@regionh.dk
Kenneth G Andersen, MD, PhD, +45 35456643, kenneth.geving.andersen@rh.regionh.dk
About this study
Official title: Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery
This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.
Read the detailed description
This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.
- Being tested
- PECS block, Bupivacaine
- Keywords
- Anesthetics, Local, Mastectomy, Neuralgia, Nerve block
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS blockProcedure or surgery
Ultrasound guided delivery of local anesthetic between the pectoral muscles
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine Receives: Procedure: PECS block; Drug: Bupivacaine |
| Sonoanatomy | No intervention | 16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in summed pain intensity score (SPI)
SPI is a combination of pain at rest + pain on arm abduction + pain with 100kPa pressure. SPI will be taken before and 30 minutes after the PECS block
Measured: 30 minutes after blockade
Secondary outcomes (1)
Differences in quantitative sensory testing (QST) values
QST consists of sensory mapping (delineating areas of hypo/hyperesthesia and/or allodynia), warm detection thresholds, cool detection thresholds, heat pain thresholds, suprathermal heat pain response and pressure pain thresholds. These will be measured before and 30 minutes after the PECS block
Measured: 30 minutes after blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pain After Breast Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Responsible party
- Principal investigator, Nelun Wijayasinghe, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Kehlet, MD, PhD, DMsc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349581
- Sponsor's protocol ID
- H-6-2014-036
- Acronym
- PPBCS
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02349581
- Acronym / sponsor ID
- PPBCS / H-6-2014-036
- Keywords
- Anesthetics, Local, Mastectomy, Neuralgia, Nerve block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- Nov 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 29 Jan 2015 (estimated)
- 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 pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.
Detailed description
This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Procedure: PECS block, Drug: BupivacainePatients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine |
| Sonoanatomy | No intervention | –16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients, aged 18 years or over, treated for breast cancer
- Patients with persistent pain in the breast after surgical treatment for breast cancer. Their pain score must be 4 or more on the numerical rating scale (NRS).
Key exclusion criteria (11 listed)
- breast surgery within the last 12 months
- previous cosmetic surgery
- bilateral breast cancer (receiving bilateral intervention)
- pregnant or breast feeding
- neurological disease
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 blockUltrasound guided delivery of local anesthetic between the pectoral muscles | Procedure or surgery | Block |
| Bupivacaine | Drug | Block |
Primary outcome
Differences in summed pain intensity score (SPI)
Time frame: 30 minutes after blockade
SPI is a combination of pain at rest + pain on arm abduction + pain with 100kPa pressure. SPI will be taken before and 30 minutes after the PECS block
1 secondary outcome
Differences in quantitative sensory testing (QST) values
Time frame: 30 minutes after blockade
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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.
Henrik Kehlet, MD, PhD, DMsc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PECS block and Bupivacaine in people with Persistent Pain After Breast Cancer Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 11 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 29 Jan 2015. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nelun Wijayasinghe, MBBS, BSc (+45 35456643, nelun.wijayasinghe@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in summed pain intensity score (SPI) (time frame: 30 minutes after blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.