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

Postoperative Pain Clinical Trial

Official title:

Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063658
• Other study ID #: 16-827-16
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2019
• Source: Ankara University
• Contact: Menekse Ozcelik, M.D
• Phone: +905333521400
• Email: ozcelikmenekse[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: May 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Paracetamol
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 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.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine	Ankara
Turkey	Ankara University School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gago Martínez A, Escontrela Rodriguez B, Planas Roca A, Martínez Ruiz A. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0154004. doi: 10.1371/journal.pone.0154004. eCollection 2016. — View Citation

Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13. — View Citation

Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Total morphine consumption during the 24 hours of early postoperative period	The first 24 hours after the completion of the surgery
Secondary	VAS scores	VAS scores at rest, at movement, at cough will be evaluated during the first 24 hours of early postoperative period	The first 24 hours after the completion of the surgery
Secondary	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	The first 24 hours after the completion of the surgery