The Analgesic Efficacy of the Pectoral Block After Mastectomy

Study Overview
=================
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.

Official Title
-----------------
The Analgesic Efficacy of the Pectoral Block After Mastectomy

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: PEC block + General anaesthesia
* Procedure: General anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEC block<br>Ultrasound-guided PEC block after induction of general anaesthesia. | Procedure: PEC block + General anaesthesia<br>* Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.<br>|
| Sham Comparator: Control<br>No ultrasound-guided PEC block; only general anaesthesia will be provided. | Procedure: General anaesthesia<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous morphine consumption during the first 24 postoperative hours (mg) |  | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | (visual analogue scale, 0 - 10) | 2 postoperative hours | 
| Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10) | Visual analogue scale, 0 - 10) | Postoperative day 1 | 
| Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10) | Visual analogue scale, 0 - 10) | Postoperative day 2 | 
| Postoperative nausea and vomiting (yes/no) |  | Postoperative day 1 | 
| Postoperative nausea and vomiting (yes/no) |  | Postoperative day 2 | 
| Pruritus (yes/no) |  | Postoperative day 1 | 
| Pruritus (yes/no) |  | Postoperative day 2 |