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

NCT05494281 | Unknown DMC

• 1 other identifier: USB_22 Trial
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Chronic Pain intensity and quality

  3 months after surgery

• Neuropathic pain screening

  3 months after surgery

• Morphine consumption

  0-24 hours after operation

Study Arms (2)

Placebo

EXPERIMENTAL

Procedure: Serratus Anterior Plane Block with saline solution

Serratus anterior plane block

EXPERIMENTAL

Procedure: Serratus Anterior Plane Block with local anesthetic

Interventions

Serratus Anterior Plane Block with local anesthetic 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.

Serratus anterior plane block

Serratus Anterior Plane Block with saline solution 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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moroccan Society of Surgery: lead

Study Sites (1)

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

Rabat, 10100, Morocco

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Interventions

Anesthetics, Local; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Abdelilah GHANNAM, MD

  Mohammed V University in Rabat

  STUDY DIRECTOR

Central Study Contacts

Abdelilah GHANNAM, MD

CONTACT

+212661382585; a.ghannam@um5r.ac.ma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 31, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)