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Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

Primary Purpose

Acute Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine
placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing lumbar discectomy

Exclusion Criteria:

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

Sites / Locations

  • DiabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

duloxitine group

placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2018
Last Updated
July 3, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03549026
Brief Title
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy
Official Title
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy: Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
duloxitine group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Measure Information:
Title
the first 24 hour morphine consumption
Description
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
Time Frame
the first postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing lumbar discectomy Exclusion Criteria: Patients on regular opioid therapy Uncontrolled hypertensive patients Patients with ischemic heart disease
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diab Hetta, MD
Phone
+201091090009
Email
diabgetta25@gmail.com

12. IPD Sharing Statement

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Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

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