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Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

Primary Purpose

Modified Radical Mastectomy, Postoperative Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acetaminophen group
Duloxetine group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Modified Radical Mastectomy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III

Exclusion Criteria:

Known Allergies to duloxetine.

  • Abnormal liver or renal function tests.
  • Narrow angle glaucoma.
  • Being a chronic opioid abuser (more than 3 months)
  • Being on chronic gabapentin or pregabalin (more than 3 months)
  • Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine.
  • Pregnant female
  • Patients with psychiatric disorders or seizure disorders.

Sites / Locations

  • Tanta University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acetaminophen group

Duloxetine group

Arm Description

patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.

Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen (every 6 hours postoperatively)

Outcomes

Primary Outcome Measures

Total morphine consumption
Postoperative Total morphine consumption will be recorded

Secondary Outcome Measures

First analgesic request
First analgesic request will be recorded
Post-operative pain
Post-operative pain will be assessed by visual analogue score (VAS) from 0-10 scale 0 (no pain) to 10 (the worst imaginable pain) at 2,4,6 h then every 6h
Heart rate
Heart rate will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Mean arterial blood pressure
Mean arterial blood pressure will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Adverse effects
Hypotension, Bradycardia, nausea, dry mouth,diarrhea, constipation,insomnia, somnolence, fatigue, hyperhidrosis and pruritus will be observed and treated accordingly

Full Information

First Posted
June 28, 2022
Last Updated
July 16, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05442268
Brief Title
Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy
Official Title
Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.
Detailed Description
Inadequate control of postoperative pain is associated with increased length of hospital stay, increased hospital cost, sleep disturbance, depression, functional impairment and affects the quality of life. Modified is one of the commonly performed procedures which is associated with severe postoperative pain. Preemptive analgesia is the analgesic treatment initiated before the surgical procedure to prevent central sensitization from the noxious stimuli. Drugs such as gabapentin, pregabalin, serotonin-norepinephrine reuptake inhibitors, dexamethasone, and cyclooxygenase-2 inhibitors have been used for preemptive analgesia. There are contrary results about the role of duloxetine in mangement of acute postoperative pain. Arecent meta-analysis was done in 2020 that concluded that the currently available evidence does not support the clinical use of duloxetine for the management of acute postoperative pain,so we will discuss that in this study. There are many studies that have shown that perioperative use of duloxetine for a few days has a significant effect on reducing postoperative pain and analgesic requirements. Duloxetine is a dual anti-depressant drug that inhibits the neuronal reuptake of serotonin (5-HT) and norepinephrine (NE) modulating the descending inhibitory pain pathways by increasing the availability of serotonin and norepinephrine. Duloxetine is an approved drug for the treatment of post-traumatic depression, major depression, and generalized anxiety disorder. It is also approved for the treatment of various chronic painful syndromes, including neuropathic pain associated with diabetes, chronic musculoskeletal pain, and fibromyalgia. The mechanisms of action so far described suggest that duloxetine may be useful as an adjunct in the treatment of acute postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Modified Radical Mastectomy, Postoperative Analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen group
Arm Type
Experimental
Arm Description
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.
Arm Title
Duloxetine group
Arm Type
Experimental
Arm Description
Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen (every 6 hours postoperatively)
Intervention Type
Procedure
Intervention Name(s)
Acetaminophen group
Intervention Description
patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively
Intervention Type
Procedure
Intervention Name(s)
Duloxetine group
Intervention Description
Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen every 6 hours postoperatively
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Postoperative Total morphine consumption will be recorded
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
First analgesic request
Description
First analgesic request will be recorded
Time Frame
24 hours postoperatively
Title
Post-operative pain
Description
Post-operative pain will be assessed by visual analogue score (VAS) from 0-10 scale 0 (no pain) to 10 (the worst imaginable pain) at 2,4,6 h then every 6h
Time Frame
48 hours postoperatively.
Title
Heart rate
Description
Heart rate will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Time Frame
48 hours postoperatively
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure will be measured every 30 minutes intraoperative and at 0 hour (direct postoperative) at post anesthesia care unit then at 2,4,6 hours at ward then every 6 hours for 48 hours postoperatively
Time Frame
48 hours postoperatively
Title
Adverse effects
Description
Hypotension, Bradycardia, nausea, dry mouth,diarrhea, constipation,insomnia, somnolence, fatigue, hyperhidrosis and pruritus will be observed and treated accordingly
Time Frame
48 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III Exclusion Criteria: Known Allergies to duloxetine. Abnormal liver or renal function tests. Narrow angle glaucoma. Being a chronic opioid abuser (more than 3 months) Being on chronic gabapentin or pregabalin (more than 3 months) Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine. Pregnant female Patients with psychiatric disorders or seizure disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Elfeky, M.B.B.CH.
Phone
0 111 747 2680
Ext
+2
Email
dena154452@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
State/Province
Elgarbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Elfeky, M.B.B.CH
Ext
+20
Email
dena154452@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available under a reasonable request from the corresponding author
IPD Sharing Time Frame
one year after the end of the study

Learn more about this trial

Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

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