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Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy: Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03549026
Enrollment
70
Registered
2018-06-07
Start date
2018-01-05
Completion date
2019-12-25
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief summary

Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine for patients undergoing lumbar discectomy.

Interventions

DRUGDuloxetine

The investigator will give the patients duloxetine capsule 60 mg orally before operation (skin incision) and anesthetize them with general anesthesia, then the investigator will test the postoperative analgesic efficacy in the form of 24 h analgesic consumption

DRUGplacebo

Patients will receive single oral dose of placebo capsule, 2 hours before operation and will be anesthetized with general anesthesia that includes, Induction of anesthesia will be done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation will be achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia will be done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia will be consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing lumbar discectomy

Exclusion criteria

* Patients on regular opioid therapy * Uncontrolled hypertensive patients * Patients with ischemic heart disease

Design outcomes

Primary

MeasureTime frameDescription
the first 24 hour morphine consumptionthe first postoperative 24 hourthe first 24 hours cumulative morphine consumed by the patient via patient controlled analgesic device (PCA), set to deliver 2 mg morphine bolus with lockout interval 15 min, without background infusion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026