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CompletedNCT01670448PECBLOCUpdated Oct 3, 2019

PECBLOCK for the Treatment of Pain After Breast Surgery

An interventional study of PECBLOCK under echoguidance in Cancer and Pain, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Cancer
  • Pain

Keywords

  • Postoperative pain
  • Chronic pain prevention
  • Regional anesthesia
  • Mastectomy
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In context

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • women aged 18-85 yrs old
  • patients ASA status I-IV

Exclusion criteria

Exclusion Criteria:

  • refusal of the PECBLOCK
  • allergy to a drug used in the protocol (local anesthetic)
  • patients with chronic pain before the surgery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Active comparator
    PECBLOCK performed with bupivacaine

    Active drug given through PECBLOCK in these patients.

    Procedure: PECBLOCK under echoguidance

  • Placebo comparator
    PECBLOCK performed with NaCl 0.9%

    Placebo drug given through PECBLOCK in these patients

    Procedure: PECBLOCK under echoguidance

Interventions

  • ProcedurePECBLOCK under echoguidance

    Performance of block under echography

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: in the recovery room before discharge (after 1 h on average))

Other outcomes

  1. Total sufentanil consumption during surgery

    When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.

    Time frame: at the end of surgery (1-2 h on average)

  2. Assess any complication from PECBLOCK

    Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?

    Time frame: first 24 hours post surgery

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Study locations

2 sites
  • CHUM
    Montreal, Quebec H2W 1T8, Canada
  • University Hospital, Limoges
    Limoges, 87042, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01670448
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
University Hospital, Limoges
Responsible party
Sponsor
First posted
Aug 22, 2012
Start date
Jan 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Oct 3, 2019

Study contacts

Jérôme Cros, MD
principal investigator · CHU Limoges
Pierre Beaulieu, MD
principal investigator · CHUM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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