Acetaminophen vs Placebo for Postoperative Analgesia After Abdominal Surgery
ConditionPain, Postoperative
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKonya City Hospital
About this trial
This study investigates whether oral acetaminophen, when added to standard pain management, reduces opioid use and pain after major abdominal surgery, compared to a placebo (inactive pill). Patients undergoing planned abdominal surgery under general anesthesia will be randomly assigned to receive either acetaminophen or a placebo tablet before surgery and every 6 hours afterward for 48 hours, in addition to their usual pain medication. Researchers will measure how much opioid pain medication patients need, how much pain they report, and how satisfied they are with their pain control during the first two days after surgery. The goal is to determine whether oral acetaminophen provides a genuine benefit beyond placebo in reducing opioid use while maintaining adequate pain control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age ≥ 18 years
ASA physical status I, II, or III
Scheduled for elective non-cardiac abdominal surgery with expected surgery duration ≥ 2 h-hours
Disqualifiers
Pregnant or nursing (breastfeeding) women
Neurologic deficit or chronic pain disease
Planned use of regional anesthesia techniques for postoperative pain
Emergency surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Acetaminophen
DrugIntervention 1: Acetaminophen (Type: Drug) Oral acetaminophen 1000 mg tablet, administered 30 minutes before surgery and every 6 hours postoperatively until 48 hours after surgery. Other Name(s): Paracetamol Intervention 2: Placebo (Type: Other / Drug) Oral placebo tablet, visually identical to the acetaminophen tablet, administered on the same schedule (30 minutes before surgery and every 6 hours postoperatively until 48 hours after surgery).
Treatment groups
1,504 Participants
are divided into 2 treatment groupsGroup A: AcetaminophenActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Postoperative Opioid Consumption
Cumulative opioid consumption during the first 48 postoperative hours, expressed as intravenous morphine milligram equivalents (MME). Tramadol consumption will be converted using a potency equivalence factor of 0.15 relative to morphine.
Time frame
48 hours after surgery2
Average Postoperative Pain Score
Average postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain. Pain will be assessed every 30 minutes during the first 2 hours in the recovery area, then approximately every 6 hours thereafter until 48 hours postoperatively.
Time frame
48 hours after surgerySecondary outcomes
1
Patient Satisfaction with Postoperative Pain Management
Patient-reported satisfaction with postoperative pain management, assessed at 24 and 48 hours postoperatively using the question: "How do you rate your pain management?" on a 0-10 scale, where 0 = very bad and 10 = excellent.
Time frame
24 and 48 hours after surgeryOther outcomes
1
Composite Opioid-Related Symptom Distress
Composite score of opioid-related side effects assessed using the Opioid-Related Symptom Distress Scale (ORSDS), evaluating 12 symptoms (nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness, dizziness, confusion, fatigue, itchiness, dry mouth, and headache) across three dimensions (frequency, severity, bothersomeness), each scored 0-4. The composite ORSDS is the mean of all 12 symptom-specific scores, with possible scores ranging from 0 to 4.
Time frame
48 hours after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Konya City Hospital
Lead sponsor
Erzurum Regional Training & Research Hospital
Collaborator
Source ClinicalTrials.gov
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