Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer (USB22)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelilah GHANNAM, MD; Phone Number: +212661382585; Email: a.ghannam@um5r.ac.ma

Study Locations

• Morocco
  • Rabat, Morocco, 10100
    • Recruiting
    • Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat
    • Contact: Abdelilah GHANNAM, MD; Phone Number: +212661382585; Email: a.ghannam@um5r.ac.ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Procedure: Serratus Anterior Plane Block with saline solution; 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
Experimental: Serratus anterior plane block	Procedure: Serratus Anterior Plane Block with local anesthetic; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Moroccan Society of Surgery
• Investigators: Study Director: Abdelilah GHANNAM, MD, Mohammed V University in Rabat

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 6, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms; Chronic Pain; Mastodynia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: USB_22 Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No