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CompletedNCT07320781Updated Jan 8, 2026

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

An interventional study of Tapentadol and Placebo in Breast Cancer, sponsored by Shaukat Khanum Memorial Cancer Hospital & Research Centre. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Shaukat Khanum Memorial Cancer Hospital & Research Centre · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Tapentadol
  • Breast Cancer Surgery
  • Morphine
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 70 is close to the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre is the lead sponsor of 23 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patient refusal
  2. CKD greater than 3
  3. BMI greater than 35
  4. Known drug allergy -
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Tapentadol

    Control drug (Tapentadol )

    Drug: Tapentadol

  • Placebo comparator
    Placebo

    Placebo sodium bicarbonate/ peppermint oil tablet

    Other: Placebo

Interventions

  • DrugTapentadol

    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.

  • OtherPlacebo

    Placebo tablet was given in group B.

06

What researchers measure

Primary outcomes

  1. Intraoperative and postoperative morphine consumption

    During the course of surgery and up to 4 hours surgery Intraoperative and postoperative morphine consumption.

    Time frame: During the course of surgery and up to 4 hours surgery

07

Study locations

1 site
  • SKMCH & RC Lahore
    Lahore, Punjab Province 042, Pakistan
08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD. Due to confidentiality of patients data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07320781
Lead sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Responsible party
Sponsor
First posted
Jan 6, 2026
Start date
Nov 15, 2024
Primary completion
Sep 30, 2025
Completion
Oct 10, 2025
Last update
Jan 8, 2026

Study contacts

Dr. Allah Ditta Ashfaq
study director · Shaukat Khanam Memorial Cancer Hospital & Research Centre LAHORE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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