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Trial Title:
Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery
NCT ID:
NCT06502067
Condition:
Breastcancer
Perioperative Pain
Inflammation
Conditions: Official terms:
Breast Neoplasms
Inflammation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Analgesia mangement group A,B
Description:
1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes
before the end of the operation .
Arm group label:
Arm B: (control group) patients will only receive general anesthesia without block.
Arm group label:
will receive serratus posterior superior block using bupivacaine
Summary:
To study the efficiacy of serratus posterior superior block in controlling perioperative
breast cancer surgery pain and its effect on inflamatory markers.
Detailed description:
Back ground The presence of pain during the initial course of treatment in women with
early-stage breast cancer was associated with significantly higher levels of c-reactive
protein(CRP) ,interleukin-7(IL-7)and interleukin-13(IL-13) There is evidence of
effectiveness of regional block in controlling inflamatory markers Serratus posterior
superior intercostal plane block (SPSIPB) is a novel Regional technique that provides
analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in
controlling pain after Video assisted thoracoscopic surgery there are little
epidemiological data on (SPSIPB)usage in masectomy and lumpectomy procedures and its
effect on inflamatory markers
Methodology:
- Type of the Study: Randomized prospective comparative controlled double-blinded
study
- Study Setting: Ain Shams University Hospitals
- Study Period: One year after approval of the protocol.
- Place :Ain shams university hospitals
- Study Population: Adult patients who will undergo breast cancer surgey.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults undergoing unilateral breast surgery under general anesthesia
- Age 21 to 60 years with body mass index (BMI)=18 to 25 kg/m2
- American Society of Anesthesiologists (ASA) grade I-III.
Exclusion Criteria:
- Patients with Long-time use of analgesic drugs
- Past history of chest surgery,
- Allergy to local anesthetics,
- Systemic infection,
- Cognitive and language disorders precluding participation,
- Patients with coagulopathy,anticoagulant users
- hemodynamic unstable patients
- Patients with neurology, spinal, psychiatry diseases
- infection at block site
- patients refused to participate in the study .
Gender:
Female
Minimum age:
21 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
July 25, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06502067