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Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Parecoxib + paracetamol
Normal saline
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring postoperative pain, multimodal anagesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Sirirat TribuddharatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group P

Group C

Arm Description

Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.

Receives normal saline in the same process.

Outcomes

Primary Outcome Measures

Postoperative morphine consumption
Postoperative morphine requirement

Secondary Outcome Measures

Postoperative pain score
Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement
Postoperative nausea/vomiting score
Postoperative nausea/vomiting score (0-3; higher score means a worse score)
Quality of life score
WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome)

Full Information

First Posted
February 22, 2023
Last Updated
April 12, 2023
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT05757388
Brief Title
Efficacy of Parecoxib Combined With Paracetamol in Mastectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
postoperative pain, multimodal anagesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group P receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction or group C receives the normal saline in the same process.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Normal saline is prepared in the same packages as parecoxib and paracetamol.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group P
Arm Type
Experimental
Arm Description
Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Receives normal saline in the same process.
Intervention Type
Drug
Intervention Name(s)
Parecoxib + paracetamol
Other Intervention Name(s)
Study drugs
Intervention Description
Administers after induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
placebo
Intervention Description
Administers after induction of anesthesia.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Postoperative morphine requirement
Time Frame
Up to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement
Time Frame
Up to 3 months postoperatively
Title
Postoperative nausea/vomiting score
Description
Postoperative nausea/vomiting score (0-3; higher score means a worse score)
Time Frame
Up to 24 hours postoperatively
Title
Quality of life score
Description
WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome)
Time Frame
Up to 24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thepakorn Sathitkarnmanee, MD
Phone
66-81-9547622
Email
thepakorns@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thepakorn Sathitkarnmanee, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Sirirat Tribuddharat
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16698416
Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Results Reference
background
PubMed Identifier
11465563
Citation
Woolf CJ, Max MB. Mechanism-based pain diagnosis: issues for analgesic drug development. Anesthesiology. 2001 Jul;95(1):241-9. doi: 10.1097/00000542-200107000-00034. No abstract available.
Results Reference
background
PubMed Identifier
16785836
Citation
Schug SA. The role of COX-2 inhibitors in the treatment of postoperative pain. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S82-6. doi: 10.1097/00005344-200605001-00015.
Results Reference
background
PubMed Identifier
22313079
Citation
Brett CN, Barnett SG, Pearson J. Postoperative plasma paracetamol levels following oral or intravenous paracetamol administration: a double-blind randomised controlled trial. Anaesth Intensive Care. 2012 Jan;40(1):166-71. doi: 10.1177/0310057X1204000121.
Results Reference
background
PubMed Identifier
26882922
Citation
Nonaka T, Hara M, Miyamoto C, Sugita M, Yamamoto T. Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial. J Anesth. 2016 Jun;30(3):405-9. doi: 10.1007/s00540-016-2150-0. Epub 2016 Feb 16.
Results Reference
background
PubMed Identifier
29066931
Citation
Schug SA, Parsons B, Li C, Xia F. The safety profile of parecoxib for the treatment of postoperative pain: a pooled analysis of 28 randomized, double-blind, placebo-controlled clinical trials and a review of over 10 years of postauthorization data. J Pain Res. 2017 Oct 10;10:2451-2459. doi: 10.2147/JPR.S136052. eCollection 2017.
Results Reference
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Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

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