Acute Pain, Postoperative Pain
Conditions
Keywords
Ibuprofen, Paracetamol, Laparoscopic cholecystectomy, Morphine, Visual analog scale
Brief summary
This study will evaluate two different analgesic regimen used for acute postoperative pain.
Detailed description
Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects. Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.
Interventions
DRUGParacetamol
The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
DRUGIbuprofen 800 mg
The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologist Functional Status 1-2 2. Body mass index smaller than 30 3. Undergoing laparoscopic cholecystectomy 4. Age between 18-60 years
Exclusion criteria
1. Age under 18, above 60 2. Weight under 40 kg 3. Body mass index above 30 4. Contraindication for opioid and non-steroid anti-inflammatory drug usage 5. Allergy against paracetamol, opioids and anti-inflammatory drugs 6. Peptic ulcer 7. Tendency to bleeding 8. Pregnancy or breast feeding 9. Moderate or severe renal, hepatic or cardiac insufficiency 10. Coronary artery disease 11. Asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | The first 24 hours after the completion of the surgery | Total morphine consumption during the 24 hours of early postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS scores | The first 24 hours after the completion of the surgery | VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period |
| Morphine side effects | The first 24 hours after the completion of the surgery | Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMenekse Ozcelik, M.D
Outcome results
None listed