Intraoperative Pectoral Block vs IV Analgesia for Pain Af... | NCT07257874

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

NCT07257874

Sponsor

Islamabad Medical and Dental College

Status

Completed

Last Update Posted

May 15, 2026Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Mastectomy, Modified Radical

Interventions

bupivacaine 0.5% injection
Ketorolac 30 mg IV

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Actual

Primary Completion Date

Dec 15, 2025Actual

Completion Date

Dec 15, 2025Actual

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Dec 1, 2025

First Posted Date

Dec 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PECs Arm	Experimental		Drug: bupivacaine 0.5% injection
IV Analgesia Arm	Active Comparator		Drug: Ketorolac 30 mg IV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine 0.5% injection	Drug	Intra-Operative Pectoral Block in Patients Undergoing Modified Radical Mastectomy for Post operative Pain management	PECs Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akbar Niazi Teaching Hospital		Islamabad		44000	Pakistan

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D007267	Injections
D020910	Ketorolac

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided