Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Phase: NA
Conditions: Postoperative Pain Management
Sponsor: Inonu University

19.04.2017 
 
Title page 
 
 
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine 
Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled 
Clinical Trial 
 
Beyza Salman Balbaba, Dr. Anesthesiology and Reanimation, City Hospital, Elazığ, Turkey 
*Sedat Akbas, Assoc. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Ahmet Selim Ozkan, Assoc. Prof. Department of Anesthesiology and Reanimation, Inonu 
University Medical Faculty, Malatya, Turkey 
Görkem Tuncay, Assoc. Prof. Department of Obstetrics and Gynecology, Inonu University 
Medical Faculty, Malatya, Turkey 
Abdullah Karaer, Prof. Department of Obstetrics and Gynecology, Inonu University Medical 
Faculty, Malatya, Turkey 
Saim Yologlu, Prof. Department of Biostatistics, Inonu University Medical Faculty, Malatya, 
Turkey 
Mahmut Durmuş, Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
 
 
Address all correspondence to: 
Sedat Akbas, Assoc. Prof. Department of Anesthesiology and Reanimation, Inonu University 
Medical Faculty, Malatya, Turkey 
Mail: drsedatakbas@gmail.com 
Phone Number: +905058263912  
Fax Number: +904223410728 

19.04.2017 
 
 
 
Study Protocol 
 
After approval from the Ethics Committee of Inonu University Medical Faculty, study was performed for 66 
patients scheduled for an elective hysterectomy surgery under general anesthesia. Patients with American Society 
of Anesthesiologists (ASA) scores 1-3 and between 18-65 years were included in this study. Patients with ASA 
score IV, under the age of 18, over the age of 65, peptic ulcer disease, hepatic and renal dysfunction, severe 
cardiovascular and pulmonary disease, allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen 
and morphine, emergency surgery and refused informed consent form were excluded from the study. 
All patients were instructed to use intravenous patient-controlled analgesia (IV PCA). After premedication patients 
were taken to the operating room. Standard monitoring with noninvasive blood pressure (NIBP), heart rate (HR), 
peripheral oxygen saturation (SpO2) and electrocardiography (ECG) was performed to all. After opening the 
peripheral vein, anesthesia induction was administered to all patients via intravenous route; propofol 2-2.5 mg/kg, 
fentanyl 1 μg/kg, rocuronium 0.6 mg/kg. Anesthesia was maintained with sevoflurane (%2-2.5) and 40% oxygen 
in oxygen-air mixture during the surgery. 
The patients were divided randomly and double blind into three groups: Group C (control, saline, n=22), Group P 
(paracetamol, n=22) and Group I (ibuprofen, n=22). Analgesic drugs were administered 30 minutes before the end 
of surgery with 250 ml saline for group C, 1 g paracetamol for group P and 800 mg ibuprofen (diluted with 250 
ml saline). After the neuromuscular block was returned at the end of the surgery, patients were tarnsfered to 
postoperative care unit. All patients received morphine with intravenous patient controlled analgesia (IV PCA) 
device during postoperative 24 hours. The PCA solution was prepared with 100 mg morphine in 200 mL of saline 
(0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min. After 
following up for approximately 1 hour in the postoperative care unit, patients were transferred to gynecology and 
obstetrics service. 
All drug administrations were applied through IV infusion over 30 minutes. The first drug administration of each 
group was given at the time of wound closure and then repeated every 6 hours in all groups for postoperative 24 
hours. HR, systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), 
respiratory rate (RR), VAS score, RAMSEY sedation score, demand, delivery and total morphine consumption of 
PCA, presence of nausea-vomiting, pruritus, rash and urine retention were recorded postoperatively at after 
awakening of anesthesia, 1th, 2th, 6th, 12th and 24th hours. Patients were not administered with antiemetic 

19.04.2017 
 
 
 
prophylaxis. Patients were treated with ondansetron (0.15 mg/kg, IV) if the presence of nausea-vomiting in the 
postoperative period. If VAS scores of the patients were above 4 in the postoperative period, 2 mg morphine was 
administered via IV. 
Statistical Analysis 
 
Statistical analysis were carried out by using SPSS program (SPSS for Windows version 22). ANOVA Test were 
used for the comparison between groups. Correlation analysis was based on the calculation of Pearson’s rank 
correlation coefficients. Value of p below 0.05 was considered as statistically significant. Consent to conduct the 
study was obtained from Local Ethic Committee of Inonu University.