Comparıson of Analgesıc Effıcacy of Dıfferent Volumes of Spsıp Block After Modıfıed Radıcal Mastectomy Surgery

June 23, 2026 updated by: Oguz Gundogdu, Cumhuriyet University

Comparıson of Analgesıc Effectıveness of Dıfferent Volumes of Posterıor Superıor Intercostal Plane Block In Patıents Undergoıng 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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).
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).
Active Comparator: Group 2
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).
Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.125% bupivacaine
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).
Active Comparator: Group 3
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).
Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.125% bupivacaine
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total tramadol consumption
Time Frame: Postoperative 24 hours
Postoperative total analgesic need was recorded as "milligram" in unit.
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30th minute after the block
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
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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