Post Operative Pain
Conditions
Keywords
postoperative pain, multimodal anagesia
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.
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.
Interventions
DRUGParecoxib + paracetamol
Administers after induction of anesthesia.
DRUGNormal saline
Administers after induction of anesthesia.
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Normal saline is prepared in the same packages as parecoxib and paracetamol.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | Up to 24 hours postoperatively | Postoperative morphine requirement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | Up to 3 months postoperatively | Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement |
| Postoperative nausea/vomiting score | Up to 24 hours postoperatively | Postoperative nausea/vomiting score (0-3; higher score means a worse score) |
| Quality of life score | Up to 24 hours postoperatively | WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome) |
Countries
Thailand
Contacts
Primary ContactThepakorn Sathitkarnmanee, MD
Outcome results
None listed