CancerPECBLOCNCT01670448
PECBLOCK for the Treatment of Pain After Breast Surgery
A study testing PECBLOCK under echoguidance in people with Cancer and Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in 2 countries.
Trial summary
Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- What is being tested?
- PECBLOCK under echoguidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Jun 2015
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged 18-85 yrs old
- patients ASA status I-IV
Who cannot join
- refusal of the PECBLOCK
- allergy to a drug used in the protocol (local anesthetic)
- patients with chronic pain before the surgery
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.
- Being tested
- PECBLOCK under echoguidance
- Keywords
- Postoperative pain, Chronic pain prevention, Regional anesthesia, Mastectomy
- Medical subject headings
- Neoplasms, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECBLOCK under echoguidanceProcedure or surgery
Performance of block under echography
| Study group | Role | What they receive |
|---|---|---|
| PECBLOCK performed with bupivacaine | Active comparator | Active drug given through PECBLOCK in these patients. Receives: Procedure: PECBLOCK under echoguidance |
| PECBLOCK performed with NaCl 0.9% | Placebo comparator | Placebo drug given through PECBLOCK in these patients Receives: Procedure: PECBLOCK under echoguidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score at rest in the recovery room
Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
Measured: 30 min after entering the recovery room or just before morphine administration if needed
Secondary outcomes (1)
Total morphine consumption in the recovery room
When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded
Measured: in the recovery room before discharge (after 1 h on average))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
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 CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Limoges
- Responsible party
- Sponsor
- Investigators
- Jérôme Cros, MD, Principal investigator, CHU LimogesPierre Beaulieu, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670448
- Sponsor's protocol ID
- CE12.231
- Acronym
- PECBLOC
- Status last verified
- Jul 2015
- First submitted
- 17 Aug 2012
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cros J, Senges P, Kaprelian S, Desroches J, Gagnon C, Labrunie A, Marin B, Crepin S, Nathan N, Beaulieu P. Pectoral I Block Does Not Improve Postoperative Analgesia After Breast Cancer Surgery: A Randomized, Double-Blind, Dual-Centered Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):596-604. doi: 10.1097/AAP.0000000000000779.
PubMed 29672368
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
- ClinicalTrials.gov ID
- NCT01670448
- Acronym / sponsor ID
- PECBLOC / CE12.231
- Keywords
- Postoperative pain, Chronic pain prevention, Regional anesthesia, Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- University Hospital, Limoges
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Aug 2012 (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.
Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.
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 |
|---|---|---|
| PECBLOCK performed with bupivacaine | Active comparator | Procedure: PECBLOCK under echoguidanceActive drug given through PECBLOCK in these patients. |
| PECBLOCK performed with NaCl 0.9% | Placebo comparator | Procedure: PECBLOCK under echoguidancePlacebo drug given through PECBLOCK in these patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women aged 18-85 yrs old
- patients ASA status I-IV
Key exclusion criteria (3 listed)
- refusal of the PECBLOCK
- allergy to a drug used in the protocol (local anesthetic)
- patients with chronic pain before the surgery
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 |
|---|---|---|
| PECBLOCK under echoguidancePerformance of block under echography | Procedure or surgery | PECBLOCK performed with NaCl 0.9%, PECBLOCK performed with bupivacaine |
Primary outcome
Pain score at rest in the recovery room
Time frame: 30 min after entering the recovery room or just before morphine administration if needed
Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
1 secondary outcome
Total morphine consumption in the recovery room
Time frame: in the recovery room before discharge (after 1 h on average))
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 3 Oct 2019.
- Derived from this study: PubMed 29672368Cros J, Senges P, Kaprelian S, Desroches J, Gagnon C, Labrunie A, Marin B, Crepin S, Nathan N, Beaulieu P. Pectoral I Block Does Not Improve Postoperative Analgesia After Breast Cancer Surgery: A Randomized, Double-Blind, Dual-Centered Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):596-604. doi: 10.1097/AAP.0000000000000779.
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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.
Jérôme Cros, MD principal investigator
CHU Limoges
Pierre Beaulieu, MD principal investigator
CHUM
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECBLOCK under echoguidance in people with Cancer and Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in 2 countries.
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 3 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 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, France. 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?
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?
Pain score at rest in the recovery room (time frame: 30 min after entering the recovery room or just before morphine administration if needed). 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 NCT01670448, 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 3 Oct 2019.