Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07670078

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.125% bupivacaine

Procedure

A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.125% bupivacaine (10 ml of the drug + 30 ml of isotonic solution).

Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.125% bupivacaine

Procedure

A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.125% bupivacaine (12.5 ml of the drug + 37.5 ml of isotonic solution).

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

Procedure

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 outcomes

  1. Total tramadol consumption

    Time frame: Postoperative 24 hours

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

Secondary outcomes

  1. Dermatome Area

    Time frame: 30th minute after the block

    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.

  2. Numeric Rating Scale (NRS) Scores

    Time frame: Postoperative 24 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

OĞUZ GÜNDOĞDU

CONTACT

[email protected]

+905545945469

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.