NCT07197177

Brief Summary

This prospective randomized controlled trial was conducted at the Department of Anesthesia, Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC), Lahore. The sample size was calculated based on a previous study by Gad M. (2019) on patients undergoing modified radical mastectomy , where the mean morphine consumption in first 24 hours post operatively was reported as 16.7 ± 7.21 mg in the erector spinae plane (ESP) block group and 10.7 ± 3.12 mg in the pectoral plane block (PECS) group. Using the formula for comparison of two means with unequal standard deviations, and assuming a 90% power, 95% confidence interval, and a 10% dropout rate, the required sample size was determined to be 42 patients, with 21 patients in each group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 19, 2025

Last Update Submit

September 19, 2025

Conditions

Cancer

Keywords

Regional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Mean Morphine consumption

    calculate morphine consumption intraoperatively and post operative at 12 hours

    12 hours

Study Arms (2)

PECTORAL PLANE BLOCK

EXPERIMENTAL

We will infiltrate local anesthesia in Pectoral Plane under ultrasound guidance.

Procedure: regional block

ERECTOR SPINAE PLANE BLOCK

EXPERIMENTAL

We will infiltrate local anesthesia in ERECTOR spine Plane under ultrasound guidance.

Procedure: regional block

Interventions

regional blockPROCEDURE

We will infiltrate local anesthesia (Bupivicaine 0.25 %), in pectoral plane vs Erecter spine plane, will observe intraoperative morphine consumption, pain scores and Pacu stay.

ERECTOR SPINAE PLANE BLOCKPECTORAL PLANE BLOCK

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status II or III, biopsy proven breast cancer, and were undergoing unilate l modified radical mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skmch & Rc

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 29, 2025

Study Start

January 10, 2021

Primary Completion

December 25, 2021

Study Completion

December 25, 2021

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

PA(1)