Postoperative Pain Clinical Trial
Official title:
Comparison Between Ketamine and Tramadol for Pain Management After Major Upper Abdominal Surgery
The purpose of the study is the comparison between ketamine and tramadol, regarding the analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA) morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia scheme, which can be applied to the clinical work and refine the analgesia provided for major procedures which require increased postoperative opioids doses. In the study, half of patients will receive continuous intravenous infusion of tramadol and Patient Controlled Analgesia morphine and the other half will receive continuous intravenous infusion of ketamine and Patient Controlled Analgesia morphine postoperatively after major upper abdominal surgery. The successful combination of different drugs targets at the improvement of the analgesia provided, the reduction of complications and the exploitation of the pharmacodynamic properties of each drug.
This is a single blind, prospective, randomized controlled trial. Forty two adults patients
of American Society of Anesthesiologists (ASA) physical status I-II, aged 18-70yr, scheduled
for elective upper abdominal surgery under general anaesthesia are recruited. Signed
informed consent is obtained from all patients. Patients are randomized into two groups.
1. Ketamine group: thirty minutes before the expected end of surgery, ketamine is
administered IV at a load dose of 0.5mg/kg followed by a continuous infusion of
ketamine (0.12mg•kg-¹•h-¹) for up to 48 h.
2. Tramadol group: thirty minutes before the expected end of surgery, tramadol is
administered IV at a load dose of 1mg/kg followed by a continuous infusion of tramadol
(0.2mg•kg-¹•h-¹) for up to 48 h.
The evening before the elective surgery, all patients are premedicated with 150 mg
ranitidine and 100mg hydroxyzine orally and provided with instructions on how to use the PCA
device. They are also explained the Visual Analogue Scale (VAS: 0-10).
All participants received the same protocol of general anaesthesia. Before the induction of
anaesthesia all patients received metoclopramide 10 mg, ranitidine 50 mg and dimethindene 4
mg intravenously. Anaesthesia was induced with propofol 2 mg/kg, and fentanyl 2 mcg/kg,
while the administration of rocuronium facilitates the trachea intubation. The anaesthesia
maintenance is attained through continuous infusion of propofol 1%. After the induction of
anaesthesia and before the surgical incision, patients receive 3 mcg/kg fentanyl and
0.1mg/kg morphine intravenously, while repetitive doses of morphine 0.05 mg/kg are
administered in order to keep intraoperative systolic arterial pressure and heart rate
within the range of 20% of the baseline values. The total morphine consumption is recorded.
Thirty minutes before the expected end of surgery, paracetamol 1gr is administered
intravenously. Consequently, patients receive either ketamine or tramadol according to the
study group, at the aforementioned bolus and continuous infusions doses. The pump remained
attached to the intravenous line for 48 hours.
After the anaesthesia recovery patients are transferred to the Postanaesthesia Care Unit,
where pain is assessed using the VAS (0-10) and treated with morphine bolus doses of 2 mg IV
to achieve VAS scores <4. When VAS score <4 is attained, a PCA morphine pump is connected to
a peripheral intravenous line and set to deliver morphine at a bolus dose of 1 mg with a
lockout period of 8 minutes.
When patients are full recovered and stabilized, are transferred to the wards. Postoperative
analgesia consisted of PCA morphine and continuous infusion of either ketamine in the
ketamine-group or tramadol in the tramadol-group, respectively. If analgesia is not adequate
and VAS >5, morphine rescue doses of 2 mg are given intravenously. If the repetitive
morphine doses are not efficient, the interval time of the PCA morphine pump is set at 6
minutes. Metoclopramide 10 mg is prescribed to be given intravenously twice a day.
Postoperative nausea and vomiting (PONV) is assessed with a 5-points scale (0-4). If PONV is
>2, dexamethasone 8 mg is given as first line treatment, while ondansetron 4 mg is the
second line treatment. Itching is treated with propofol 10 mg IV. If the symptom continues,
the patient is removed from the study.
The study period is 48 hours (1, 2, 4, 6, 12, 18, 24, 36 and 48 hours) considering as zero
time, the time of the connection of the PCA morphine pump to the patient. At these time
points, morphine consumption, VAS scores, oxygen saturation, respiratory rate, bradycardia,
hypotension, postoperative day of patient's mobilization, complications, drugs' side effects
(itching, seizures, illusions, confusion, disorientation, sense of dry mouth, urinary
retention, sedation, quality of sleep, PONV,) ability to cough are assessed. Additionally,
patient's overall satisfaction at 48 hours is assessed and the postoperative total
intrahospital stay is also recorded.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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