Intraoperative Pectoral Block vs IV Analgesia for Pain After Modified Radical Mastectomy

NCT ID: NCT07257874

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Mastectomy, Modified Radical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PECs Arm

Group Type EXPERIMENTAL

bupivacaine 0.5% injection

Intervention Type DRUG

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

IV Analgesia Arm

Group Type ACTIVE_COMPARATOR

Ketorolac 30 mg IV

Intervention Type DRUG

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

Interventions

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bupivacaine 0.5% injection

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

Intervention Type DRUG

Ketorolac 30 mg IV

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Islamabad Medical and Dental College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Akbar Niazi Teaching Hospital

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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No.179/IMDC/IREB-2025

Identifier Type: -

Identifier Source: org_study_id

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