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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