Efficacy of Parecoxib Combined With Paracetamol in Mastectomy

NCT ID: NCT05757388

Last Updated: 2023-04-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2023-05-10

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Normal saline is prepared in the same packages as parecoxib and paracetamol.

Study Groups

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Group P

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

Group Type EXPERIMENTAL

Parecoxib + paracetamol

Intervention Type DRUG

Administers after induction of anesthesia.

Group C

Receives normal saline in the same process.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Administers after induction of anesthesia.

Interventions

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Parecoxib + paracetamol

Administers after induction of anesthesia.

Intervention Type DRUG

Normal saline

Administers after induction of anesthesia.

Intervention Type DRUG

Other Intervention Names

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Study drugs placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Thepakorn Sathitkarnmanee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thepakorn Sathitkarnmanee, MD

Role: STUDY_CHAIR

Khon Kaen University

Locations

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Dr. Sirirat Tribuddharat

Khon Kaen, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thepakorn Sathitkarnmanee, MD

Role: CONTACT

66-81-9547622

References

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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.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11465563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16785836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22313079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26882922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29066931 (View on PubMed)

Other Identifiers

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HE641269

Identifier Type: -

Identifier Source: org_study_id

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