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

NCT07670078 | Not Yet Recruiting

• 1 other identifier: 2026-0167
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain, Acute; Facial Plane Blocks; Modified Radical Mastectomy

Keywords

postoperative pain; regional anesthesia; Modified radical mastectomy; opioid free analgesia; facial plan block; serratus posterior superior intercostal plane block

Outcome Measures

Primary Outcomes (1)

• Total tramadol consumption

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

  Postoperative 24 hours

Secondary Outcomes (2)

• Dermatome Area

  30th minute after the block

• Numeric Rating Scale (NRS) Scores

  Postoperative 24 hours

Study Arms (3)

30 ml of 0.25% Bupivacaine

ACTIVE COMPARATOR

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

40 ml of 0.125% Bupivacaine

ACTIVE COMPARATOR

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

50 ml of 0.125% bupivacaine

ACTIVE COMPARATOR

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

Interventions

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).

50 ml of 0.125% bupivacaine

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).

30 ml of 0.25% Bupivacaine

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).

40 ml of 0.125% Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

OĞUZ GÜNDOĞDU

CONTACT

+905545945469; oguzgundogdu@cumhuriyet.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)