Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757388
• Other study ID #: HE641269
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: May 10, 2023

Study information

• Verified date: March 2023
• Source: Khon Kaen University
• Contact: Thepakorn Sathitkarnmanee, MD
• Phone: 66-81-9547622
• Email: thepakorns[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 10, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Parecoxib + paracetamol
Administers after induction of anesthesia.
• Normal saline
Administers after induction of anesthesia.

Locations

Country	Name	City	State
Thailand	Dr. Sirirat Tribuddharat	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption	Postoperative morphine requirement	Up to 24 hours postoperatively
Secondary	Postoperative pain score	Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement	Up to 3 months postoperatively
Secondary	Postoperative nausea/vomiting score	Postoperative nausea/vomiting score (0-3; higher score means a worse score)	Up to 24 hours postoperatively
Secondary	Quality of life score	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