The Analgesic Efficacy of the Pectoral Block After Mastectomy

NCT02916381 | Completed DMC

• 1 other identifier: CER 2016-01413
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

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

  Postoperative day 1

Secondary Outcomes (9)

• Intravenous morphine consumption on postoperative day 2 (mg)

  Postoperative day 2

• Intravenous morphine consumption in phase 1 recovery (mg)

  2 postoperative hours

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

  2 postoperative hours

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

  Postoperative day 1

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

  Postoperative day 2

Study Arms (2)

PEC block

EXPERIMENTAL

Ultrasound-guided PEC block after induction of general anaesthesia.

Procedure: PEC block + General anaesthesia

Control

SHAM COMPARATOR

No ultrasound-guided PEC block; only general anaesthesia will be provided.

Procedure: General anaesthesia

Interventions

PEC block + General anaesthesia PROCEDURE

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

PEC block

General anaesthesia PROCEDURE

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Eric Albrecht

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

CH (1)