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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental |
| |
| Serratus anterior plane block | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelilah GHANNAM, MD | Contact | +212661382585 | a.ghannam@um5r.ac.ma |
| Name | Affiliation | Role |
|---|---|---|
| Abdelilah GHANNAM, MD | Mohammed V University in Rabat | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat | Recruiting | Rabat | 10100 | Morocco |
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|
| 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 |
|
| 3 months after surgery |
| Morphine consumption | Morphine rescue dose for extra need of analgesic | 0-24 hours after operation |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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