NCT06502067

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 6, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • is to calculate total perioperative analgesia consumption throughout (24hours).

    24 hour postoperative

Study Arms (2)

will receive serratus posterior superior block using bupivacaine

ACTIVE COMPARATOR

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

Arm B: (control group) patients will only receive general anesthesia without block.

OTHER

Narcotic postoperative

Drug: Analgesia mangement group A,B

Interventions

1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .

Arm B: (control group) patients will only receive general anesthesia without block.will receive serratus posterior superior block using bupivacaine

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia Mostafa Ghazy, Master degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2024

First Posted

July 15, 2024

Study Start

July 25, 2024

Primary Completion

June 2, 2025

Study Completion

July 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07