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

NCT ID: NCT07320781

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-10-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
The patient and doctor providing anesthesia were blinded.

Study Groups

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Tapentadol

Control drug (Tapentadol )

Group Type ACTIVE_COMPARATOR

Tapentadol

Intervention Type DRUG

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.

Placebo

Placebo sodium bicarbonate/ peppermint oil tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet was given in group B.

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo tablet was given in group B.

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaukat Khanum Memorial Cancer Hospital & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Allah Ditta Ashfaq

Role: STUDY_DIRECTOR

Shaukat Khanam Memorial Cancer Hospital & Research Centre LAHORE

Locations

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SKMCH & RC Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB-23-20

Identifier Type: -

Identifier Source: org_study_id

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