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

Not Applicable

Recruiting

• Conditions: Pain, Postoperative; Pain, Chronic; Post-Mastectomy Chronic Pain Syndrome; Breast Neoplasms
• Interventions: Procedure: Serratus Anterior Plane Block with saline solution; Procedure: Serratus Anterior Plane Block with local anesthetic

• Registration Number: NCT05494281
• Lead Sponsor: Moroccan Society of Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-06
• Study First Posted: 2022-08-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-02-01
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Serratus Anterior Plane Block with saline solution	-
Serratus anterior plane block	Serratus Anterior Plane Block with local anesthetic	-

Primary Outcome Measures

Name	Time	Method
chronic postoperative pain intensity	3 months after surgery	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
Chronic postoperative pain at 3 months	3 months after surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat; 🇲🇦 Rabat, Morocco