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

Phase 4

• Conditions: Postoperative Pain; Acute Pain
• Interventions: Drug: Ibuprofen 800 mg; Drug: Paracetamol

• Registration Number: NCT03063658
• Lead Sponsor: Ankara University

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2020-10-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 800 mg	Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
Paracetamol	Paracetamol	Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.

Primary Outcome Measures

Name	Time	Method
Morphine consumption	The first 24 hours after the completion of the surgery	Total morphine consumption during the 24 hours of early postoperative period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ankara University Faculty of Medicine; 🇹🇷 Ankara, Turkey

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey