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Not yet recruiting NCT07670078

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

No phase Interventional Modified Radical Mastectomy Post Operative Pain, Acute Facial Plane Blocks

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine, Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine.
Who it may be relevant to
Registry conditions: Modified Radical Mastectomy, Post Operative Pain, Acute, Facial Plane Blocks. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparıson of Analgesıc Effectıveness of Dıfferent Volumes of Serratus Posterıor Superıor Intercostal Plane Block In Patıents Undergoıng Modıfıed Radıcal Mastectomy Surgery

Overview

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.

Detailed description

The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks.

The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.

Interventions

  • Procedure Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.1875% bupivacaine
    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).
  • Procedure Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.15% bupivacaine
    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).
  • Procedure Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine
    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).

Primary outcome measures

  • Total tramadol consumption [Time frame: Postoperative 24 hours]
Secondary outcome measures (2)
  • Dermatome Area [Time frame: 30th minute after the block]
  • Numeric Rating Scale (NRS) Scores [Time frame: Postoperative 24 hours]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • patients with ineffective block
  • patients who could not cooperate during postoperative pain assessment
  • patients who wanted to withdraw from the study,
  • patients with alcohol and drug addiction,
  • patients with musculoskeletal abnormalities
  • patients with kidney and liver failure
  • patients with obesity (body mass ≥ 35 kg/m2)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Sivas Cumhuriyet University — Sivas

Identifiers

NCT: NCT07670078 · 2026-0167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗