Zagazig University , Fuculty of Medicine
Zagazig, Sharquia, 7120730, Egypt
NCT Number: NCT05990686
Postoperative pain is an important problem, especially for day case surgeries. It has negative effects on patient's hemodynamics and can cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.
Multiple analgesic strategies have been proposed including NSAID, opioids, epidural analgesia. Each of them has its limitations.
In this study the investigators will compare the effect of preemptive use of paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative pain
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Notify Me21 year–65 year
All sexes
Interventional
Phase 4
Zagazig, Sharquia, 7120730, Egypt
After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameters will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.
Patients will be randomly allocated into two equal groups:
Both groups will be induced with propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation and maintained with inhaled isoflurane and incremental doses of muscle relaxant if needed. Neuromuscular blockade will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg.
In both groups intraoperative monitoring of heart rate (beats/min) and mean arterial blood pressure (mmHg) will be documented.
Postoperatively:
In the recovery room and in the surgical ward the patient's mean blood pressure and heart rate will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also, the postoperative pain assessment for all patients will be done by an anesthesiologist (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on the visual analog scale (VAS) (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. A Quality of Recovery questionnaire (QoR-40) will be administered 24 hours postoperatively by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.
Rescue analgesia (intravenous Ketorolac 30 mg) was administered if tachycardia and/or hypertension occurred postoperatively, defined as an increase in heart rate or blood pressure of more than 25 % from baseline, or if the VAS score was 5 or higher. Time to first request for postoperatiev rescue analgesia will be recorded.
Rescue antiemetics (Ondansetron 8 mg) will be given to any patient complaining of nausea and vomiting, occurrence of other side effects including bradycardia or hypotension will be recorded and managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20% of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of ephedrine. Bradycardia, defined as a heart rate below 50 beats/min, will be managed with atropine 0.2-0.5 mg. Patient satisfaction, postoperative sedation/agitation using the Richmod Agitation-Sedation Scale (RASS), and length of postoperative hospital stay will also be recorded.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in Group T received an intravenous infusion of paracetamol (15 mg/kg) with tramadol (1 mg/kg), completed immediately before induction of anaesthesia.
Other names: tramadol
Group F received a single intravenous injection of fentanyl 1.5 µg/kg before induction.
Time frame: The QoR-40 was administered 24 hours after the surgery by an anaesthesiologist independent of the anaesthetic team and not involved in drug administration.
It will be derived from the 40-item Quality of Recovery questionnaire (QoR-40), which assesses five dimensions of postoperative recovery: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 40 items is scored from 1 (worst) to 5 (best), yielding a total score ranging from 40 to 200.
Time frame: On arrival to the recovery room and at 1, 2, 4, 6, and 12 hours postoperatively.
It will be assessed using the 10 cm visual analogue scale (VAS; 0 = no pain, 10 = worst pain imaginable) and the patient was instructed to mark along the line which pain intensity is currently being experienced.
Time frame: From arrival to the recovery room until the first request for rescue analgesia, assessed up to 24 hours postoperatively.
Document the first time for the need of rescue analgesia.
Time frame: After extubation, on arrival to the recovery room and at 10 and 20 minutes after arrival to the recovery room.
Will be assessed using the Richmond Agitation-Sedation Scale (RASS).
Time frame: Baseline (preoperatively) and on arrival to the recovery room postoperatively.
Compare mean arterial blood pressure (mmHg) between patients in both groups.
Time frame: Baseline (preoperatively) and on arrival to the recovery room postoperatively.
Compare the heart rate (beats/min) between patients in both groups.
Time frame: Up to twenty-four hours after surgery
Document the incidence of adverse events including bradycardia, hypotension, nausea, and vomiting.
Time frame: Up to twenty-four hours after surgery.
Compare the length of hospital stay in both groups.
Zagazig University
Other Gov
Paracetamol Plus Tramadol Versus Fentanyl as Pre-emptive Analgesia for Enhanced Recovery After Day-Case Surgeries: A Randomised Controlled Trial
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