Analgesic Equivalence of NSAIDs and Tramadol in Acute Postoperative Pain Following Minimally Inva… (NCT07500454) | Clinical Trial Compass
CompletedNot Applicable
Analgesic Equivalence of NSAIDs and Tramadol in Acute Postoperative Pain Following Minimally Invasive Surgery
Mexico30 participantsStarted 2024-06-20
Plain-language summary
This pilot randomised controlled trial compared the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. The primary outcome was postoperative pain intensity measured using the Numerical Rating Scale (NRS 0-10) at recovery room arrival and at 30, 60, and 90 minutes thereafter.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-55 years
* ASA physical status I or II
* Body mass index 18.5-34.99 kg/m²
* Scheduled for elective minimally invasive surgery under balanced general anaesthesia
* Pre-surgical pain NRS = 0 and VRS = "absence" at baseline assessment
Exclusion Criteria:
* Pregnancy
* Known hypersensitivity to any study drug (tramadol, ketorolac, or diclofenac)
* Pre-existing acute pain with NRS ≥ 4 or VRS ≥ "moderate" before surgery
* Chronic pain with current analgesic use
* Withdrawal of consent before premedication administration
* Surgical duration exceeding 180 minutes
* Conversion from laparoscopic to open surgical approach
* Hypersensitivity reaction during study drug administration
* Haemodynamic shock of any aetiology during the perioperative period
* Requirement for postoperative mechanical ventilation due to anaesthetic-surgical complications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared NSAIDs to tramadol for pain after minimally invasive surgery — based on what the results showed about pain intensity, which of these two approaches would you recommend for my specific procedure and situation?
2Since this trial is completed, have the findings been published yet, and do the results suggest one option is meaningfully better at controlling acute postoperative pain than the other?
3Tramadol is an opioid and NSAIDs carry their own risks like stomach or kidney issues — given my medical history, which of these pain management options would be safer for me after a minimally invasive surgery?
4This study was listed as Phase NA, meaning it wasn't testing a new drug but comparing existing treatments — does that mean the pain management approaches studied here are already available to me as standard care options after my surgery?
5If NSAIDs and tramadol turn out to be roughly equivalent for pain control, are there other factors like side effect profiles or recovery speed that should guide which one my care team would choose for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain intensity
Timeframe: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.