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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06100419
Other study ID # SPSIPB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 22, 2023
Est. completion date July 22, 2023

Study information

Verified date October 2023
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.


Description:

Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date July 22, 2023
Est. primary completion date July 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Female patients who will undergo breast surgery Exclusion Criteria: - unstable patients - patients with bleeding disorders - Patients allergic to local anesthetic drugs - Patients who did not agree to participate in the study - Patients with infection at the application site

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
serratus posterior superior intercostal plane block
With this newly introduced procedure added to the literature, patients undergoing breast surgeries are expected to experience reduced pain.

Locations

Country Name City State
Turkey Sivas Cumhuriyet University Sivas

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary numeric rate scores (NRS) The pain levels of patients are indicated with a number between 1 and 10. its means: 0=no pain, 10=worst pain. first 24 hours
Secondary total tramadol consumption The total analgesic quantity that patients will consume for pain reduction. first 24 hours
See also
  Status Clinical Trial Phase
Completed NCT00686127 - Symptom Management After Breast Cancer Surgery Phase 4
Completed NCT05825430 - Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain N/A