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Completed

NCT Number: NCT02916381

The Analgesic Efficacy of the Pectoral Block After Mastectomy

Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-III
  • Age ≥ 18
  • Patients undergoing unilateral mastectomy

Exclusion criteria

  • Contraindications to regional block
  • Pregnancy
  • Inability to give informed consent
  • History of alcohol or drug dependence/abuse
  • History of long term opioid intake or chronic pain disorder

Treatment and study plan

PEC block + General anaesthesia

Procedure

Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.

General anaesthesia

Procedure

Primary outcomes

  1. Intravenous morphine consumption during the first 24 postoperative hours (mg)

    Time frame: Postoperative day 1

Secondary outcomes

  1. Intravenous morphine consumption on postoperative day 2 (mg)

    Time frame: Postoperative day 2

  2. Intravenous morphine consumption in phase 1 recovery (mg)

    Time frame: 2 postoperative hours

  3. Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)

    Time frame: 2 postoperative hours

    (visual analogue scale, 0 - 10)

  4. Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)

    Time frame: Postoperative day 1

    Visual analogue scale, 0 - 10)

  5. Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)

    Time frame: Postoperative day 2

    Visual analogue scale, 0 - 10)

  6. Postoperative nausea and vomiting (yes/no)

    Time frame: Postoperative day 1

  7. Postoperative nausea and vomiting (yes/no)

    Time frame: Postoperative day 2

  8. Pruritus (yes/no)

    Time frame: Postoperative day 1

  9. Pruritus (yes/no)

    Time frame: Postoperative day 2

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 27, 2016
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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