Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

NCT05757388 | Unknown

• 1 other identifier: HE641269
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

postoperative pain; multimodal anagesia

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  Postoperative morphine requirement

  Up to 24 hours postoperatively

Secondary Outcomes (3)

• Postoperative pain score

  Up to 3 months postoperatively

• Postoperative nausea/vomiting score

  Up to 24 hours postoperatively

• Quality of life score

  Up to 24 hours postoperatively

Study Arms (2)

Group P

EXPERIMENTAL

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

Drug: Parecoxib + paracetamol

Group C

PLACEBO COMPARATOR

Receives normal saline in the same process.

Drug: Normal saline

Interventions

Parecoxib + paracetamol DRUG

Administers after induction of anesthesia.

Also known as: Study drugs

Group P

Normal saline DRUG

Administers after induction of anesthesia.

Also known as: placebo

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Dr. Sirirat Tribuddharat

Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (6)

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 11465563 BACKGROUND

• 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.

  PMID: 16785836 BACKGROUND

• 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.

  PMID: 22313079 BACKGROUND

• 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.

  PMID: 26882922 BACKGROUND

• 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.

  PMID: 29066931 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxib; Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Thepakorn Sathitkarnmanee, MD

  Khon Kaen University

  STUDY CHAIR

Central Study Contacts

Thepakorn Sathitkarnmanee, MD

CONTACT

66-81-9547622; thepakorns@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Normal saline is prepared in the same packages as parecoxib and paracetamol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 7, 2023
• Study Start: March 28, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 10, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)