Breast Neoplasms, Pain, Chronic, Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome
Conditions
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.
Interventions
PROCEDURESerratus 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.
PROCEDURESerratus 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
Sponsors
Moroccan Society of Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic postoperative pain at 3 months | 3 months after surgery | 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 |
| chronic postoperative pain intensity | 3 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain intensity and quality | 3 months after surgery | Pain intensity of patients was evaluated by Arabic version of Brief pain inventory |
| Neuropathic pain screening | 3 months after surgery | Neuropathic pain will be screened by Douleur Neuropathique 4 score |
| Morphine consumption | 0-24 hours after operation | Morphine rescue dose for extra need of analgesic |
Countries
Morocco
Contacts
Primary ContactAbdelilah GHANNAM, MD
Outcome results
None listed