Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer

Study Overview
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Brief Summary
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Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem. The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.

Official Title
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Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial

Conditions
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Breast Neoplasms, Pain, Postoperative, Pain, Chronic, Post-Mastectomy Chronic Pain Syndrome

Intervention / Treatment
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* Procedure: Serratus Anterior Plane Block with local anesthetic
* Procedure: Serratus Anterior Plane Block with saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having an age greater than or equal to 18 years and less than 70 years Having given written consent for participation in the study and the use of personal and medical data Having a physical status of class I, II or III of the American Society of Anesthesiologists Exclusion Criteria: Patients who expressed their refusal to participate in the study Patients unable to express their non-objection to participation in the study American Society of Anesthesiologists class > III patients Known allergy to local anesthetics A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site) Morbid obesity (body mass index greater than 40 kg/m²) Chronic use of opioids Inability to use the patient controlled analgesia device The existence of preoperative pain History of neuropathy or neurological pathology The existence of catastrophism or anxiety diagnosed preoperatively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br> | Procedure: Serratus Anterior Plane Block with saline solution<br>* A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the in-plane view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of saline solution<br>|
| Experimental: Serratus anterior plane block<br> | Procedure: Serratus Anterior Plane Block with local anesthetic<br>* A deep analgesic block of the Serratus anterior plane block (SAPB) type by echo-guided lateral approach will be performed by An 8-13 Mhz high frequency linear ultrasound probe witch will be located cranio-caudally, transversely to the 3rd and 4th intercostal space on the mid-axillary line while patients are supine with the ipsilateral upper limb raised to 90°. Once the landmark anatomical structures have been identified (upper rib, lower rib, pleural line, Serratus muscle, superficial structures), the puncture will begin Under aseptic conditions, an 80 mm 22 gauge needle will be inserted into the in-plane view of the ultrasound probe. When the needle has reached the plane under Serratus between the Serratus muscle and the intercostal muscle opposite the lower edge of the upper rib, 30 ml of 1% Lidocaine will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain at 3 months | A question will be asked to patients : Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery?  The answer yes or no will determine the outcome | 3 months after surgery | 
| chronic postoperative pain intensity | Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Pain intensity and quality | Pain intensity of patients was evaluated by Arabic version of Brief pain inventory | 3 months after surgery | 
| Neuropathic pain screening | Neuropathic pain will be screened by Douleur Neuropathique 4 score | 3 months after surgery | 
| Morphine consumption | Morphine rescue dose for extra need of analgesic | 0-24 hours after operation |