NCT07561853

Brief Summary

Postoperative pain after mastectomy remains a significant clinical problem that may impair patient comfort and delay early rehabilitation, potentially affecting functional recovery. Various analgesic techniques are used to manage postoperative pain. This study aims to compare serratus posterior superior intercostal plane block and erector spinae plane block, which are routinely used in our clinic for postoperative analgesia in patients undergoing mastectomy, in terms of ease of application and patient comfort.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
7mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Serratus Posterior Superior Intercostal Plane BlockErector Spinae Plane BlockMastectomyPostoperative PainFascial Plane Block

Outcome Measures

Primary Outcomes (1)

  • Ease of block application (procedure difficulty score)

    The ease of application of the block will be evaluated using a 10-point numerical rating scale (0-10), where lower scores indicate easier application and higher scores indicate greater procedural difficulty. The score will be assigned by the anesthesiologist performing the block immediately after completion of the procedure.

    Immediately after block performance

Secondary Outcomes (2)

  • Postoperative pain score at 24 hours

    24 hours postoperatively

  • Quality of recovery at 24 hours

    24 hours postoperatively

Study Arms (2)

Serratus Posterior Superior Intercostal Plane Block Group

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.

Procedure: Serratus posterior superior intercostal plane block

Erector Spinae Plane Block Group

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.

Procedure: Erector Spinae Plane Block

Interventions

Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.

Serratus Posterior Superior Intercostal Plane Block Group

Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.

Erector Spinae Plane Block Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 25-65 years American Society of Anesthesiologists (ASA) physical status I-III Patients scheduled for mastectomy under general anesthesia Patients with no history of previous breast surgery Patients who provide written informed consent to participate in the study

You may not qualify if:

  • ASA physical status IV and above History of alcohol or substance abuse Known allergy to local anesthetics or opioids Patients with severe psychiatric disorders Patients who refuse to participate or do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
This study is designed as a triple-blind trial. Participants, perioperative care providers, and outcome assessors will be blinded to group allocation. Randomization will be performed using a computer-generated sequence, and group assignments will be concealed in sealed, opaque envelopes. The anesthesiologist performing the block will not be involved in postoperative care or outcome assessment. To maintain blinding, block procedures will be performed under standardized conditions, and patients will not be informed about the specific block type administered. Outcome data will be collected by investigators who are unaware of the assigned intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups to receive either a serratus posterior superior intercostal plane (SPSIP) block or an erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The study is designed as a parallel-group trial. Randomization will be performed using a computer-generated sequence. Blinding will be maintained such that the patient, the care providers responsible for perioperative management, and the outcome assessors are unaware of group allocation. Only the anesthesiologist performing the block will be aware of the assigned intervention and will not be involved in postoperative data collection or outcome assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Specialist

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share