Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

April 12, 2023 updated by: Thepakorn Sathitkarnmanee, Khon Kaen University

The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial

Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Dr. Sirirat Tribuddharat

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with breast cancer undergoing elective mastectomy
  • ASA physical status 1-3

Exclusion Criteria:

  • Allergy to parecoxib, paracetamol, or sulfonamide
  • History of opioid use
  • Pregnant
  • Renal or hepatic disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group P
Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.
Drug: Parecoxib + paracetamol
Administers after induction of anesthesia.
Other Names:
  • Study drugs
Placebo Comparator: Group C
Receives normal saline in the same process.
Drug: Normal saline
Administers after induction of anesthesia.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morphine consumption
Time Frame: Up to 24 hours postoperatively
Postoperative morphine requirement
Up to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: Up to 3 months postoperatively
Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement
Up to 3 months postoperatively
Postoperative nausea/vomiting score
Time Frame: Up to 24 hours postoperatively
Postoperative nausea/vomiting score (0-3; higher score means a worse score)
Up to 24 hours postoperatively
Quality of life score
Time Frame: Up to 24 hours postoperatively
WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome)
Up to 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Khon Kaen University

Investigators

  • Study Chair: Thepakorn Sathitkarnmanee, MD, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 28, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE641269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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