Clinical trial NCT03063658: Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain
Official title: Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pain
Postoperative Pain
Keywords: Ibuprofen
Paracetamol
Laparoscopic cholecystectomy
Morphine
Visual analog scale
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: The first 24 hours after the completion of the surgery
Secondary outcomes:
measure: VAS scores
timeFrame: The first 24 hours after the completion of the surgery
measure: Morphine side effects
timeFrame: The first 24 hours after the completion of the surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Ankara University Department of Anesthesiology and Intensive Care Medicine
name: Zekeriyya Alanoglu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Gago Martinez A, Escontrela Rodriguez B, Planas Roca A, Martinez 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.
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.