Phase 4
Completed N=60
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Source: ClinicalTrials.gov NCT02535000 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. — 726; 503; 180; 136 micrograms
Summary
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. |
726; 503; 180; 136 | — |
| SECONDARY Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). |
2.27; 2.14; 2.67; 2.28; 2.10; 2.07 | — |
Eligibility Criteria
Inclusion Criteria
- Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study
Exclusion Criteria
- Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.
Data sourced from ClinicalTrials.gov (NCT02535000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.