Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

Ankara University108 enrolled

Overview

This study will evaluate two different analgesic regimen used for acute postoperative pain.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

108

Conditions

Acute Pain Postoperative Pain

Interventions

ParacetamolDRUG

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.

Ibuprofen 800 mgDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

ACTIVE_NOT_RECRUITING

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Morphine consumption

Total morphine consumption during the 24 hours of early postoperative period

Time frame: The first 24 hours after the completion of the surgery

Secondary Outcomes

VAS scores

VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period

Time frame: The first 24 hours after the completion of the surgery

Morphine side effects

Morphine side effects such as nausea, vomiting, pruritus, constipation, urinary retention will be evaluated during the first 24 hours of early postoperative period

Time frame: The first 24 hours after the completion of the surgery

Central Contacts

Menekse Ozcelik, M.D

CONTACT

+905333521400 ozcelikmenekse@yahoo.com

Data from ClinicalTrials.gov

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