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

Pain, Postoperative Clinical Trial

— USB22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494281
• Other study ID #: USB_22 Trial
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2022
• Source: Moroccan Society of Surgery
• Contact: Abdelilah GHANNAM, MD
• Phone: +212661382585
• Email: a.ghannam[@]um5r.ac.ma
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: July 31, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chronic Pain
• Mastodynia
• Pain, Chronic
• Pain, Postoperative
• Post-Mastectomy Chronic Pain Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Morocco	Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat	Rabat

Sponsors (1)

Lead Sponsor	Collaborator
Moroccan Society of Surgery

Country where clinical trial is conducted

Morocco, 

Outcome

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