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

A

Ain Shams University

Status

Not yet enrolling

Conditions

Perioperative Pain
Inflammation
Breastcancer

Treatments

Drug: Analgesia mangement group A,B

Study type

Interventional

Funder types

Other

Identifiers

NCT06502067
MD94/2024

Details and patient eligibility

About

To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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 .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

will receive serratus posterior superior block using bupivacaine
Active Comparator group
Description:
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.
Treatment:
Drug: Analgesia mangement group A,B
Arm B: (control group) patients will only receive general anesthesia without block.
Other group
Description:
Narcotic postoperative
Treatment:
Drug: Analgesia mangement group A,B

Trial contacts and locations

0

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Central trial contact

Dalia Mostafa Ghazy, Master degree

Data sourced from clinicaltrials.gov

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