Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery

Not Applicable

Not yet recruiting

• Conditions: Breastcancer; Perioperative Pain; Inflammation
• Interventions: Drug: Analgesia mangement group A,B

• Registration Number: NCT06502067
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-14
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Study Start: 2024-07-25
• Primary Completion: 2025-06-02
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
will receive serratus posterior superior block using bupivacaine	Analgesia mangement group A,B	between the SPSM and the 3rd rib after using a test dose of 1- 2 mL saline and Following hydro-dissection,30ml 0.25%bupivacaine will be injected.
Arm B: (control group) patients will only receive general anesthesia without block.	Analgesia mangement group A,B	Narcotic postoperative

Primary Outcome Measures

Name	Time	Method
is to calculate total perioperative analgesia consumption throughout (24hours).	24 hour postoperative