NCT07320781

Brief Summary

This study evaluated the preemptive analgesic efficacy of Tapentadol in reducing peri operative analgesic requirements among patients undergoing breast cancer surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 21, 2025

Last Update Submit

January 6, 2026

Conditions

Breast Cancer

Keywords

TapentadolBreast Cancer SurgeryMorphine

Outcome Measures

Primary Outcomes (1)

  • Intraoperative and postoperative morphine consumption

    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

Study Arms (2)

Tapentadol

ACTIVE COMPARATOR

Control drug (Tapentadol )

Drug: Tapentadol

Placebo

PLACEBO COMPARATOR

Placebo sodium bicarbonate/ peppermint oil tablet

Other: Placebo

Interventions

TapentadolDRUG

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.

Tapentadol
PlaceboOTHER

Placebo tablet was given in group B.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • ASA 1,2,3
  • Patients scheduled for breast conservation surgery -

You may not qualify if:

  • Patient refusal
  • CKD greater than 3
  • BMI greater than 35
  • Known drug allergy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKMCH & RC Lahore

Lahore, Punjab Province, 042, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Dr. Allah Ditta Ashfaq

    Shaukat Khanam Memorial Cancer Hospital & Research Centre LAHORE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The patient and doctor providing anesthesia were blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

November 15, 2024

Primary Completion

September 30, 2025

Study Completion

October 10, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

PA(1)