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Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

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ClinicalTrials.gov Identifier: NCT03549026
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Diab Fuad Hetta, Assiut University

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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Duloxetine Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy: Randomized Trial
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: duloxitine group
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
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 Comparator: placebo group
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
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




Primary Outcome Measures :
  1. the first 24 hour morphine consumption [ Time Frame: the first postoperative 24 hour ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing lumbar discectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549026


Locations
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Egypt
Diab Recruiting
Assiut, Assuit, Egypt, 71515
Contact: Diab Hetta, MD    +201091090009    diabgetta25@gmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Diab Fuad Hetta, lecturer of anesthesia and pain management , Assuit university, Assiut University
ClinicalTrials.gov Identifier: NCT03549026     History of Changes
Other Study ID Numbers: SECI-IRB-IORG0006563-535
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Atropine
Fentanyl
Duloxetine Hydrochloride
Anesthetics
Propofol
Isoflurane
Analgesics
Neostigmine
Atracurium
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents