Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

NCT03549026 | Unknown

• 1 other identifier: SECI-IRB-IORG0006563-535
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

duloxitine group

EXPERIMENTAL

Patients will receive single oral dose of duloxetine capsule, 60 mg, 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.

Drug: Duloxetine

placebo group

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

Duloxetine DRUG

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

duloxitine group

placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lumbar discectomy

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and pain management , Assuit university

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 7, 2018
• Study Start: January 5, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 25, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

EG (1)