PainPhase 3NCT02336529
Nerveblocks for Persistent Pain After Breast Cancer Surgery
A Phase 3 study testing Bupivacaine and NaCl in people with Pain and Neuropathic Pain, run by Kenneth Geving Andersen.
Trial summary
Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Neuropathic Pain, Breast Cancer
- What is being tested?
- Bupivacaine and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Phase 3
- 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
- At least 1 year after surgery for breast cancer
- Women aged 18 or over
- Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)
Who cannot join
- Previous cosmetic surgery
- bilateral cancer
- pregnant or lactating
- other disease in the nervous system
- in treatment for psychiatric disease
- unable to understand Danish
- unable to give informed concent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.
- Conditions
- Pain, Neuropathic Pain, Breast Cancer
- Being tested
- Bupivacaine, NaCl
- Keywords
- postoperative
- Medical subject headings
- Pain, Neuralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
NaClDrug
| Study group | Role | What they receive |
|---|---|---|
| ICBN, active | Experimental | Ultrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN Receives: Drug: Bupivacaine |
| ICBN, placebo | Placebo comparator | Ultrasound guided injection of NaCl, 10mL in proximity of the ICBN Receives: Drug: NaCl |
| Tenderpoint, active | Experimental | Ultrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint Receives: Drug: Bupivacaine |
| Tenderpoint, placebo | Placebo comparator | Ultrasound guided injection of NaCl, 20mL in the tenderpoint Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed pain intensity
The summed pain intensity (of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)) 0-30
Measured: At least 1 year after surgery
Secondary outcomes (2)
Pain at rest, pain during movement and pressure pain
Pain intensity of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)
Measured: At least 1 year after surgery
Pain related reduction of physical function
Reduction of physical function
Measured: At least 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (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 PainStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenneth Geving Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Geving Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Nelun Wijayasinghe, MD, Principal investigator, Rigshospitalet, University of CopenhagenKenneth G Andersen, MD, PhD, Study chair, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336529
- Sponsor's protocol ID
- H-3-2013-172
- Status last verified
- Oct 2015
- First submitted
- 8 Jan 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.
PubMed 24918332
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02336529
- Acronym / sponsor ID
- H-3-2013-172
- Conditions
- Pain, Neuropathic Pain, Breast Cancer
- Keywords
- postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kenneth Geving AndersenUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 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.
Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICBN, active | Experimental | Drug: BupivacaineUltrasound guided injection of bupivacain, 10mL, 0.5% in proximity of the ICBN |
| ICBN, placebo | Placebo comparator | Drug: NaClUltrasound guided injection of NaCl, 10mL in proximity of the ICBN |
| Tenderpoint, active | Experimental | Drug: BupivacaineUltrasound guided injection of bupivacain, 20mL, 0.25% in the tenderpoint |
| Tenderpoint, placebo | Placebo comparator | Drug: NaClUltrasound guided injection of NaCl, 20mL in the tenderpoint |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 1 year after surgery for breast cancer
- Women aged 18 or over
- Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)
Key exclusion criteria (7 listed)
- Previous cosmetic surgery
- bilateral cancer
- pregnant or lactating
- other disease in the nervous system
- in treatment for psychiatric 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 |
|---|---|---|
| Bupivacaine | Drug | ICBN, active, Tenderpoint, active |
| NaCl | Drug | ICBN, placebo, Tenderpoint, placebo |
Primary outcome
Summed pain intensity
Time frame: At least 1 year after surgery
The summed pain intensity (of pain at rest (0-10), pain during movement (0-10) and pressure pain (at 100kPa in point of maximum pain) (0-10)) 0-30
2 secondary outcomes
Pain at rest, pain during movement and pressure pain
Time frame: At least 1 year after surgery
Pain related reduction of physical function
Time frame: At least 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Background: PubMed 24918332Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Nelun Wijayasinghe, MD principal investigator
Rigshospitalet, University of Copenhagen
Kenneth G Andersen, MD, PhD study chair
Rigshospitalet, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and NaCl in people with Pain and Neuropathic Pain, run by Kenneth Geving Andersen.
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 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 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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, MD (+4535454496, nelun.wijayasinghe@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed pain intensity (time frame: At least 1 year 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 NCT02336529, 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 27 Oct 2015.