Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549026
• Other study ID #: SECI-IRB-IORG0006563-535
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: December 25, 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 25, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients undergoing lumbar discectomy

Exclusion Criteria:

• Patients on regular opioid therapy

• Uncontrolled hypertensive patients

• Patients with ischemic heart disease

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Duloxetine
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
• placebo
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

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the first 24 hour morphine consumption	the 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	the first postoperative 24 hour