Duloxetine for Acute Post-mastectomy Pain

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468348
• Other study ID #: SECI-IRB-IORG0006563-437
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Duloxetine
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.

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the first postoperative 24 hour
Secondary	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 outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
Secondary	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 questionnair will be assessed once, 24 hour postoperatively
Secondary	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 score will be measured at 8 hour, 16 hour and 24 hour postoperatively
Secondary	The occurrence of vomiting	vomiting is forceful discharge of stomach contents	The outcome will be obtained once 24 hour postoperatively