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

July 22, 2024 updated by: Ain Shams University

Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Perioperative Analgesia and Inflamatory Markers in Breast Surgery

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: will receive serratus posterior superior block using bupivacaine
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.
Drug: Analgesia mangement group A,B
1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .
Other: Arm B: (control group) patients will only receive general anesthesia without block.
Narcotic postoperative
Drug: Analgesia mangement group A,B
1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
is to calculate total perioperative analgesia consumption throughout (24hours).
Time Frame: 24 hour postoperative
24 hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

June 2, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 6, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD94/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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