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Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine 60mg
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

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

Inclusion Criteria:

  • adult patients, subjected to major abdominal cancer surgery

Exclusion Criteria:

  • patients on chronic opioid therapy
  • patients allergic to study drugs (duloxetine+morphine)
  • patients have uncontrolled hypertension and or ischemic heart disease

Sites / Locations

  • Diab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

duloxetine+morphine

placebo+morphine

Arm Description

Outcomes

Primary Outcome Measures

time to first analgesic request
the time elapsed from (0 hour = immediately postoperative) to time of first demand to analgesic

Secondary Outcome Measures

Full Information

First Posted
May 19, 2018
Last Updated
March 16, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03560427
Brief Title
Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine
Official Title
Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine in Major Abdominal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 14, 2020 (Actual)

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 combined with intrathecal morphine for patients subjected to major abdominal cancer surgery

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
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
duloxetine+morphine
Arm Type
Experimental
Arm Title
placebo+morphine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine 60mg
Intervention Description
Patients will receive duloxetine, 60 mg tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space. General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was 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)
placebo
Intervention Description
Patients will receive placebo tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space. General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was 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
time to first analgesic request
Description
the time elapsed from (0 hour = immediately postoperative) to time of first demand to analgesic
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, subjected to major abdominal cancer surgery Exclusion Criteria: patients on chronic opioid therapy patients allergic to study drugs (duloxetine+morphine) patients have uncontrolled hypertension and or ischemic heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diab Hetta, MD
Organizational Affiliation
Lectuere of anesthesia and pain management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diab
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

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Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

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