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Pain, PostoperativePhase 4BPCAMNCT03040167

The Pectoral Block for Breast Augmentation Surgery

A Phase 4 study testing PEC 1 block, Bupivacaine with epinephrine and Normal saline in people with Pain, Postoperative and Anesthesia; Regional, run by Pierre Beaulieu at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. Injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative, Anesthesia; Regional
What is being tested?
PEC 1 block, Bupivacaine with epinephrine and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
2 sitesCanada
Study dates
1 Oct 2017to 29 Mar 2018
Phase
Phase 4
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 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • breast augmentation surgery
  • registration at régie d'assurance maladie du Québec (RAMQ) (social services)

Who cannot join

  • known bleeding disorder
  • anticoagulant intake
  • infection at site of PEC 1 block
  • pregnant or breast-feeding women
  • allergy to bupivacaine
  • chronic pain including fibromyalgia with regular analgesic consumption
Show all 9Show fewer
  • under recreational drugs or alcohol at doses above canadian recommendations
  • muscle relaxants intake
  • patients already operated for breast augmentation or mastectomy

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CHUM

    Montreal, Quebec, H2W 1T8

  • CISSS des Laurentides

    Saint-Jérôme, Quebec

Other trials in Canada

About this study

Official title: The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.

The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. Injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block. This block has not been well characterized in terms of its blocking effects on motor and sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical trial is divided into two sections: a volunteer study and a patient study.

For the volunteer study, the aim is to assess the sensory territory affected by injection of local anesthetics through a PEC 1 block and to assess motor function in terms of strength of adduction of the affected limb using a dynamometer.

In a prospective, randomized, controlled and double blind study, the aim is to assess the postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral breast augmentation surgery.

Being tested
PEC 1 block, Bupivacaine with epinephrine, Normal saline
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEC 1 blockProcedure or surgery

    Also called pectoral block, pecblock

    Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.

  • Bupivacaine with epinephrineDrug

    Treatment group

  • Normal salineDrug

    Placebo group

Study groups in NCT03040167
Study groupRoleWhat they receive
Control groupPlacebo comparatorPEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.
Receives: Procedure: PEC 1 block; Drug: Normal saline
Treatment groupActive comparatorPEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.
Receives: Procedure: PEC 1 block; Drug: Bupivacaine with epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Within the first 10 min after arrival to the postanesthesia care unit (PACU)

Secondary outcomes (6)

  1. Postoperative pain score on movement

    Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)

    Measured: Within the first 10 min after arrival to the postanesthesia care unit (PACU)

  2. 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: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU

  3. Incidence of nausea and/or vomiting

    Presence or absence of nausea and/or vomiting

    Measured: 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU

  4. Surgical bleeding

    Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration

    Measured: After surgery for 24 hours

  5. Hematoma

    Presence or absence of hematoma at PEC 1 block injection

    Measured: After surgery for 24 hours

  6. Postoperative well-being

    Analgesic intake

    Measured: At 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2017 (estimated)
  2. Study start1 Oct 2017
  3. Primary completion12 Mar 2018
  4. Study completion29 Mar 2018

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03040167
Sponsor's protocol ID
17.091
Acronym
BPCAM
Status last verified
Mar 2018
First submitted
29 Jan 2017
Last updated
10 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desroches J, Belliveau M, Bilodeau C, Landry M, Roy M, Beaulieu P. Pectoral nerves I block is associated with a significant motor blockade with no dermatomal sensory changes: a prospective volunteer randomized-controlled double-blind study. Can J Anaesth. 2018 Jul;65(7):806-812. doi: 10.1007/s12630-018-1122-2. Epub 2018 Mar 29.

    PubMed 29600482

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEC 1 block, Bupivacaine with epinephrine and Normal saline in people with Pain, Postoperative and Anesthesia; Regional, run by Pierre Beaulieu at 2 sites in Canada.

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 9 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 10 Dec 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. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postoperative pain score at rest (time frame: Within the first 10 min after arrival to the postanesthesia care unit (PACU)). 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 NCT03040167, 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 10 Dec 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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