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Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome

ConditionsAmantadineDuloxetinePregabalinMastectomyPain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCairo University

About this trial

This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years.

American society of anesthesiologists (ASA) Physical status II, III.

Body mass index (BMI): (20-40) kg/m2.

Type of surgery: patients undergoing modified radical mastectomy for breast cancer.

Disqualifiers

Patient refusal.

Patients with Known sensitivity or contraindication to drug used in the study.

History of psychological disorders and/or chronic pain and drug abuse patients.

Previous administration of antidepressants, anticonvulsants, or opioids before surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregabalin

    Drug

    Two hours preoperative patient will receive one capsule of Pregabalin 75 mg (Lyrica 75 mg, Viatris) and) and one placebo tablet and will continue on both of them twice daily for seven days postoperative

  • Pregabalin + Amantadine

    Drug

    Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma) and will continue on both twice daily for seven days postoperative.

  • Pregabalin + Duloxetine

    Drug

    Two hours preoperative patient will receive one capsule of pregabalin 75 mg (Lyrica 75 mg, Viatris) and one capsule of Duloxetine 30 mg (Cymbatex 30 mg, EVA Pharma) and will continue on both twice daily for seven days postoperative.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group P (Pregabalin group)Active comparator 1 intervention
Group B: Group PA (Pregabalin + Amantadine group)Experimental treatment 1 intervention
Group C: Group PD (Pregabalin + Duloxetine group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rate of occurrence of post mastectomy pain syndrome

The rate of occurrence of post mastectomy pain syndrome will be recorded according to Grading system for neuropathic pain (GSNP). GSNP is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite), the patients will be considered positive regarding incidence being in grade 3 or 4.

Time frame
12 weeks post-procedure

Secondary outcomes

1

Patient's Quality of life

Patient's Quality of life will be assessed using Flanagan Quality of Life Scale (QOLS) which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patients and the total score will be calculated and recorded at the preoperative assessment (baseline) and at postoperative weeks 2, 4, 8,12.

Time frame
12 weeks post-procedure
2

Patient's activity level

Postoperative patient's activity level will be assessed using Barthel Activities of Daily Living scale (ADL). This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help.

Time frame
12 weeks post-procedure
3

Degree of pain

Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

Time frame
12 weeks post-procedure
4

Total amount of fentanyl

Total amount of fentanyl consumed intraoperative will be recorded.

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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