NCT07257874

Brief Summary

There is difference in post operative pain between patients receiving inter- pectoral block and those receiving standard Intravenous analgesia(INJ TORADOL) in patients undergoing Modified Radical Mastectomy. To compare between these two methods , which one is better for post operative pain management.

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 below P25 for phase_3

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 19, 2025

Last Update Submit

December 1, 2025

Conditions

Mastectomy, Modified Radical

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Severity at 24 hours Measured by Numeric Pain Rating Scale from 0-10 , where 0 is no pain and 10 is severe pain.

    24 hours Post Surgery

Study Arms (2)

PECs Arm

EXPERIMENTAL
Drug: bupivacaine 0.5% injection

IV Analgesia Arm

ACTIVE COMPARATOR
Drug: Ketorolac 30 mg IV

Interventions

bupivacaine 0.5% injectionDRUG

Intra-Operative Pectoral Block in Patients Undergoing Modified Radical Mastectomy for Post operative Pain management

PECs Arm
Ketorolac 30 mg IVDRUG

Ketorolac 30mg administered Intravenously as a standard practice for post operative pain management in modified radical mastectomy

IV Analgesia Arm

Eligibility Criteria

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

You may qualify if:

  • Female Patients undergoing Modified Radical Mastectomy for biopsy proven Carcinoma Breast
  • Patient with age 18-65 years
  • Patients with ASA Grade 2
  • BMI less than 40 kg/meter square

You may not qualify if:

  • Block site infection
  • Coagulopathies (INR \> 1.6 and Platelets \< 100000)
  • Any Organ dysfunction such as severe cardiac, pulmonary, renal or liver dysfunction
  • Systemic infection
  • Dementia
  • Known hypersensitivity to local anesthetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akbar Niazi Teaching Hospital

Islamabad, 44000, Pakistan

Location

MeSH Terms

Interventions

BupivacaineInjectionsKetorolac

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeuticsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 2, 2025

Study Start

July 1, 2025

Primary Completion

December 10, 2025

Study Completion

December 15, 2025

Last Updated

December 2, 2025

Record last verified: 2025-12

Locations

PA(1)