NCT06989372

Brief Summary

Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain is observed in approximately 40% of post-mastectomy patients, moderate-to-severe pain is observed in almost one-third of them .

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 25, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

May 17, 2025

Last Update Submit

May 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    The primary outcome is the total morphine consumption of the patient in the first 24 h postoperatively.

    24 hours post operatively

Study Arms (2)

Group I (SP)

ACTIVE COMPARATOR

serratus posterior superior block

Procedure: serratus posterior superior block

Group II (ES)

ACTIVE COMPARATOR

erector spinae block

Procedure: erector spinae block

Interventions

patients were placed in the lateral decubitus position for SPSIPB. The blocks were performed under the guidance of ultrasonography (USG), a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) transducer was placed at the level of the spine scapula in the transverse plane, and the upper medial border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), 2nd and 3rd ribs were visualized. The ultrasound probe is rotated 90 degrees in a parasagittal orientation to identify the first rib. After its identification, the second and third ribs are confirmed. An 80 mm sono visible needle (type) was inserted in the caudocranial direction just medial to the scapula with the in-plane technique and driven between the 2nd and 3rd ribs targeting the inferior part of the SPSM. The target was confirmed by injecting the test dose with saline. Thirty ml of 0.25% bupivacaine was subsequently injected

Group I (SP)

US-guided ESPB, a commonly performed interfascial plane block, was first defined by Forero et al. (21). In this technique, LA is injected in the plane between the erector spinae muscles and the thoracic transverse processes. Thus, multiple thoracic levels are anesthetized by the LA spreading in a craniocaudal direction. The transducer was then placed approximately 3 cm lateral to the midline parasagittally. The T5 transverse process and the erector spinae, rhomboid major, trapezius muscles were viewed (i.e., from deep to superficial). The block needle was advanced in a craniocaudal direction using an in-plane approach through the trapezius, rhomboid major, and erector spinae muscles. After establishing contact with the hyperechoic transverse process, 30 mL of 0.25% bupivacaine was injected in small aliquots after hydrodissection (2-3 mL, 0.9% NaCl) and checking for negative blood aspiration after every 5 mL of injection.

Group II (ES)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 to 65 years
  • ASA classification I and II

You may not qualify if:

  • age below 18 or above 65 years
  • ASA classification III or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

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
Lecturer of Anesthesia, ICU and pain management

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 25, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations