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Trial Title:
Efficacy of Parecoxib Combined With Paracetamol in Mastectomy
NCT ID:
NCT05757388
Condition:
Post Operative Pain
Conditions: Official terms:
Pain, Postoperative
Acetaminophen
Parecoxib
Conditions: Keywords:
postoperative pain
multimodal anagesia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking description:
Normal saline is prepared in the same packages as parecoxib and paracetamol.
Intervention:
Intervention type:
Drug
Intervention name:
Parecoxib + paracetamol
Description:
Administers after induction of anesthesia.
Arm group label:
Group P
Other name:
Study drugs
Intervention type:
Drug
Intervention name:
Normal saline
Description:
Administers after induction of anesthesia.
Arm group label:
Group C
Other name:
placebo
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Sirirat Tribuddharat
Address:
City:
Khon Kaen
Zip:
40002
Country:
Thailand
Status:
Recruiting
Start date:
March 28, 2023
Completion date:
May 10, 2023
Lead sponsor:
Agency:
Khon Kaen University
Agency class:
Other
Source:
Khon Kaen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05757388
