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Completed

NCT Number: NCT03468348

Duloxetine for Acute Post-mastectomy Pain

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diab

Asyut, Assuit, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

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 outcomes

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

    Time frame: the first postoperative 24 hour

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

Secondary outcomes

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

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

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

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

    Time frame: the questionnair will be assessed once, 24 hour postoperatively

    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)

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

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

    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)

  4. The occurrence of vomiting

    Time frame: The outcome will be obtained once 24 hour postoperatively

    vomiting is forceful discharge of stomach contents

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2018
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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