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Clinical Trials/NCT07257874
NCT07257874
Active, not recruiting
Phase 3

Comparison Between Intra-Operative Pectoral Block and Intravenous Analgesia for Post-Operative Pain Relief in Patients Undergoing Modified Radical Mastectomy

Islamabad Medical and Dental College1 site in 1 country60 target enrollmentStarted: July 1, 2025Last updated:
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Interventionsbupivacaine 0.5% injectionKetorolac 30 mg IV

Overview

Phase
Phase 3
Status
Active, not recruiting
Sponsor
Islamabad Medical and Dental College
Enrollment
60
Locations
1
Primary Endpoint
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.
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •Known hypersensitivity to local anesthetic agents

Arms & Interventions

PECs Arm

Experimental

Intervention: bupivacaine 0.5% injection (Drug)

IV Analgesia Arm

Active Comparator

Intervention: Ketorolac 30 mg IV (Drug)

Outcomes

Primary Outcomes

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.

Time Frame: 24 hours Post Surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Islamabad Medical and Dental College
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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