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Duloxetine for Acute Post-mastectomy Pain

Primary Purpose

Acute Pain

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Duloxetine

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring duloxetine, mastectomy, postoperative pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
American Society of Anesthesiologists physical status (ASA) class I and II

Exclusion Criteria:

Patients with a known allergy to Duloxetine or morphine,
A history of drug or alcohol abuse,
Patients with impaired kidney or liver functions,
Patients with chronic pain or regularly receiving analgesics,
Any psychiatric illness that would interfere with the perception and the assessment of pain.
Any reason that resulted in the protocol violation.

Sites / Locations

Diab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo group

duloxetine 30

duloxetine 60

duloxetine 90

Arm Description

Outcomes

Primary Outcome Measures

the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption

the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h

Secondary Outcome Measures

The intensity of pain measured by visual analogue pain scale (VAS)

The intensity of pain measured by visual analogue pain scale (VAS) in which 0 = no pain and 10 = the maximum imaginable pain

The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)

It measures five components of patient recovery: physical comfort (12 questions), physical independence (5 questions), emotional state (9 questions), psychological support (7 questions), and pain (7 questions). The sum of each component generates an aggregate score that ranges from 40 (i.e., extremely poor quality of recovery) to 200 (i.e., excellent quality of recovery)

The level of consciousness assessed by "the Modified Ramsay Sedation score"

awake levels were: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = responds to command, and asleep levels were dependent on patient's response to a light glabellar tap or loud auditory stimulus; IV= brisk response; V = a sluggish response; and VI = no response)

The occurrence of vomiting

vomiting is forceful discharge of stomach contents

Full Information

NCT ID

NCT03468348

First Posted

March 11, 2018

Last Updated

June 22, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03468348

Brief Title

Duloxetine for Acute Post-mastectomy Pain

Official Title

Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

February 10, 2020 (Actual)

Study Completion Date

February 10, 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

Detailed Description

patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.

6. Conditions and Keywords

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

Acute Pain

Keywords

duloxetine, mastectomy, postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Title

duloxetine 30

Arm Type

Active Comparator

Arm Title

duloxetine 60

Arm Type

Active Comparator

Arm Title

duloxetine 90

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Intervention Description

patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

Primary Outcome Measure Information:

Title

the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption

Description

the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h

Time Frame

the first postoperative 24 hour

Secondary Outcome Measure Information:

Title

The intensity of pain measured by visual analogue pain scale (VAS)

Description

The intensity of pain measured by visual analogue pain scale (VAS) in which 0 = no pain and 10 = the maximum imaginable pain

Time Frame

The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.

Title

The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)

Description

Time Frame

the questionnair will be assessed once, 24 hour postoperatively

Title

The level of consciousness assessed by "the Modified Ramsay Sedation score"

Description

Time Frame

the score will be measured at 8 hour, 16 hour and 24 hour postoperatively

Title

The occurrence of vomiting

Description

vomiting is forceful discharge of stomach contents

Time Frame

The outcome will be obtained once 24 hour postoperatively

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer, American Society of Anesthesiologists physical status (ASA) class I and II Exclusion Criteria: Patients with a known allergy to Duloxetine or morphine, A history of drug or alcohol abuse, Patients with impaired kidney or liver functions, Patients with chronic pain or regularly receiving analgesics, Any psychiatric illness that would interfere with the perception and the assessment of pain. Any reason that resulted in the protocol violation.

Facility Information:

Facility Name

Diab

City

Assiut

State/Province

Assuit

ZIP/Postal Code

71515

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

32847776

Citation

Hetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22.

Results Reference

derived

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Duloxetine for Acute Post-mastectomy Pain

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