Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients.

January 6, 2026 updated by: Shaukat Khanum Memorial Cancer Hospital & Research Centre
This study evaluated the preemptive analgesic efficacy of Tapentadol in reducing peri operative analgesic requirements among patients undergoing breast cancer surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double blinded prospective RCT was conducted with 70 patients undergoing breast cancer surgery with 35 patients being studied with Administrated drug & other 35 as placebo. Intraoperative & postoperative morphine consumption was calculated and documented.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 042
        • SKMCH & RC Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-60 years
  2. ASA 1,2,3
  3. Patients scheduled for breast conservation surgery -

Exclusion Criteria:

  1. Patient refusal
  2. CKD greater than 3
  3. BMI greater than 35
  4. Known drug allergy -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo sodium bicarbonate/ peppermint oil tablet
Other: Placebo
Placebo tablet was given in group B.
Active Comparator: Tapentadol
Control drug (Tapentadol )
Drug: Tapentadol
75 mg oral tapentadol given 1 hour before surgery in control group and placebo tablet was given in Group B. Intraoperative and post operative morphine consumption and pain scores at 1,2,3,4 hours were calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative and postoperative morphine consumption
Time Frame: During the course of surgery and up to 4 hours surgery
During the course of surgery and up to 4 hours surgery Intraoperative and postoperative morphine consumption.
During the course of surgery and up to 4 hours surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Investigators

  • Study Director: Dr. Allah Ditta Ashfaq, Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-23-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD. Due to confidentiality of patients data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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