Clinical trial

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

Name
HE641269
Description
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.
Trial arms
Trial start
2023-03-28
Estimated PCD
2023-05-01
Trial end
2023-05-10
Status
Recruiting
Treatment
Parecoxib + paracetamol
Administers after induction of anesthesia.
Arms:
Group P
Other names:
Study drugs
Normal saline
Administers after induction of anesthesia.
Arms:
Group C
Other names:
placebo
Size
60
Primary endpoint
Postoperative morphine consumption
Up to 24 hours postoperatively
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Normal saline is prepared in the same packages as parecoxib and paracetamol.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-04-14

1 organization

1 product

1 drug

1 indication