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

NCT ID: NCT05494281

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: EXPERIMENTAL

Serratus Anterior Plane Block with saline solution

Intervention Type: PROCEDURE

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

Serratus anterior plane block

Group Type: EXPERIMENTAL

Serratus Anterior Plane Block with local anesthetic

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Moroccan Society of Surgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdelilah GHANNAM, MD

Role: STUDY_DIRECTOR

Mohammed V University in Rabat

Locations

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

Rabat, , Morocco

Site Status: RECRUITING

Countries

Morocco

Central Contacts

Abdelilah GHANNAM, MD

Role: CONTACT

a.ghannam@um5r.ac.ma

+212661382585

Facility Contacts

Abdelilah GHANNAM, MD

Role: primary

a.ghannam@um5r.ac.ma

+212661382585

Other Identifiers

USB_22 Trial

Identifier Type: -

Identifier Source: org_study_id