The Analgesic Efficacy of the Pectoral Block After Mastectomy

Analgesia Clinical Trial

Official title:

The Analgesic Efficacy of the Pectoral Block After Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916381
• Other study ID #: CER 2016-01413
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 2019

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• PEC block + General anaesthesia
Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.
• General anaesthesia

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravenous morphine consumption during the first 24 postoperative hours (mg)		Postoperative day 1
Secondary	Intravenous morphine consumption on postoperative day 2 (mg)		Postoperative day 2
Secondary	Intravenous morphine consumption in phase 1 recovery (mg)		2 postoperative hours
Secondary	Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)	(visual analogue scale, 0 - 10)	2 postoperative hours
Secondary	Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)	Visual analogue scale, 0 - 10)	Postoperative day 1
Secondary	Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)	Visual analogue scale, 0 - 10)	Postoperative day 2
Secondary	Postoperative nausea and vomiting (yes/no)		Postoperative day 1
Secondary	Postoperative nausea and vomiting (yes/no)		Postoperative day 2
Secondary	Pruritus (yes/no)		Postoperative day 1
Secondary	Pruritus (yes/no)		Postoperative day 2