USB22: Serratus Anterior Plane Block to Prevent Chronic Postoperative Pan in Breast Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Placebo
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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
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Experimental: Serratus anterior plane block
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Procedure: 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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Having an age greater than or equal to 18 years and less than 70 years
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Having given written consent for participation in the study and the use of personal and medical data
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Having a physical status of class I, II or III of the American Society of Anesthesiologists
Exclusion Criteria:
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Patients who expressed their refusal to participate in the study
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Patients unable to express their non-objection to participation in the study
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American Society of Anesthesiologists class > III patients
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Known allergy to local anesthetics
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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)
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Morbid obesity (body mass index greater than 40 kg/m²)
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Chronic use of opioids
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Inability to use the patient controlled analgesia device
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The existence of preoperative pain
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History of neuropathy or neurological pathology
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The existence of catastrophism or anxiety diagnosed preoperatively
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat | Rabat | Morocco | 10100 |
Sponsors and Collaborators
- Moroccan Society of Surgery
Investigators
- Study Director: Abdelilah GHANNAM, MD, Mohammed V University in Rabat
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- USB_22 Trial