Continuous Pectoral Nerve Block in Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.

Detailed Description
-----------------
Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.

Official Title
-----------------
The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery

Conditions
-----------------
Nerve Blocks, Breast Surgery, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: PECS group
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology (ASA) I-II 18-65 years Body mass index (BMI) ≤40 kg/m2 Elective breast cancer surgery Exclusion Criteria: ASA ≥4 under 18 years of age or over 65 years of age declining to give written informed consent history of allergy to the local anesthetics contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc) history of breast surgery treatment due to psychiatric disorder history of treatment for chronic pain history of nerve blocks in order to treat postoperative pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PECS group<br>In addition to routine analgesic protocol; before anaesthesia induction; following the PECS I + II block, a continuous infusion catheter will be placed at the PECS II block level under the guidance of USG, and local anesthetic infusion will be started via the catheter at the end of the operation. | Procedure: PECS group<br>* Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.<br>|
| Sham Comparator: Control group<br>Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block). | Other: Control group<br>* Standard pain follow up and monitorization will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia consumption | postoperative 12 hours | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia consumption | intraoperative | during the surgery | 
| postoperative Numeric Rating Scale (NRS) score | postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12 hours | 0, 1, 3, 6, 9, 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pectoral nerve block (pecs block), breast cancer, postoperative pain, numeric rating scale score (NRS score)