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

NCT ID: NCT05494281

Condition: Breast Neoplasms
Pain, Postoperative
Pain, Chronic
Post-Mastectomy Chronic Pain Syndrome

Conditions: Official terms:
Breast Neoplasms
Chronic Pain
Pain, Postoperative
Mastodynia
Anesthetics
Anesthetics, Local

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Serratus Anterior Plane Block with local anesthetic
Description: 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.
Arm group label: Serratus anterior plane block

Intervention type: Procedure
Intervention name: Serratus Anterior Plane Block with saline solution
Description: 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
Arm group label: Placebo

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.

Criteria for 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

Gender: Female

Gender based: Yes

Gender description: Women Having to undergo an elective unilateral modified total mastectomy with dissection of the axillary lymph nodes (modified Patey procedure) for curative purposes for oncological pathology of the breast, performed in the operating room of the Gyneco-mammary center of INO, without breast reconstruction

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

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

Address:
City: Rabat
Zip: 10100
Country: Morocco

Status: Recruiting

Contact:
Last name: Abdelilah GHANNAM, MD

Phone: +212661382585
Email: a.ghannam@um5r.ac.ma

Start date: August 1, 2022

Completion date: July 31, 2023

Lead sponsor:
Agency: Moroccan Society of Surgery
Agency class: Other

Source: Moroccan Society of Surgery

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05494281

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