An interventional study of Tramadol and Paracetamol in Lumbar Disc Herniation, sponsored by Yeditepe University Hospital. Completed. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Yeditepe University Hospital · Not applicable, Interventional, and Other
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
Background:
Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.
Aims:
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
Study Design:
In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.
Methods:
Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's enrollment of 60 is close to the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Yeditepe University Hospital is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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(ASA) 1 or 2 status patients with single level lumbar disc herniation.
Exclusion Criteria:
Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose is ≥30 kg/m2 were excluded from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group Tramadol patients received tramadol 1 mg kg-1 iv
Drug: Tramadol
Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours
Drug: Tramadol · Drug: Paracetamol
Tramadol iv
Paracetamol iv
Severity of pain
Self reported pain intensity
Time frame: 2 hours
Tramadol consumption
Total tramadol consumption during time frame
Time frame: 2 hours
No study locations are listed for this record.
Plan to share: Undecided
Ran from Mar 2014 to primary completion in Jan 2015, 9 months.
Of 178 non-industry interventional studies with no phase under Intervertebral Disc Displacement, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 9 months is below that.
Counting every sponsor, half of 191 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen
Intervertebral Disc Displacement →
Yeditepe University Hospital