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Comparıson of Analgesıc Effıcacy of Dıfferent Volumes of Serratus Posterior Superıor Intercostal Plane Block After Modıfıed Radıcal Mastectomy Surgery

ConditionsModified Radical MastectomyPost Operative Pain, AcuteFacial Plane Blocks
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCumhuriyet University

About this trial

The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The study included adult patients over 18 years of age who underwent modified radical mastectomy under general anesthesia and were classified in risk groups I-II-III according to the American Society of Anesthesiologists (ASA) risk classification.

Disqualifiers

patients with coagulopathy,

patients with signs of infection at the block application site,

patients with ASA IV

patients with known allergies to any of the study drugs,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine

    Procedure/Surgery

    A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.1875% bupivacaine (15 ml of the drug + 25 ml of isotonic solution).

  • Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine

    Procedure/Surgery

    A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.15% bupivacaine (15 ml of the drug + 35 ml of isotonic solution).

  • Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine

    Procedure/Surgery

    A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: 30 ml of 0.25% BupivacaineActive comparator 1 intervention
Group B: 40 ml of 0.1875% BupivacaineActive comparator 1 intervention
Group C: 50 ml of 0.15% bupivacaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total tramadol consumption

Postoperative total analgesic need was recorded as "milligram" in unit.

Time frame
Postoperative 24 hours

Secondary outcomes

1

Dermatome Area

Thirty minutes after the block procedure, we will perform a pinprick test by inserting a sterile needle from the tip of the syringe into the patient's skin and recording the areas where skin analgesia has developed.

Time frame
30th minute after the block
2

Numeric Rating Scale (NRS) Scores

Description: Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain

Time frame
Postoperative 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cumhuriyet University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: