Breast Cancer Surgery, Post-Surgical Complication
Conditions
Keywords
pain, wound healing, post-surgery, breast cancer
Brief summary
The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing breast cancer surgery. It aims to evaluate the efficacy of pentoxifylline on postoperative pain and wound healing.
Detailed description
The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing mastectomy. It aims to evaluate the efficacy of adjuvant pentoxifylline in reducing postoperative pain and improving wound healing in breast cancer patients undergoing mastectomy surgery. Participants will take standard of care treatment with oral pentoxifylline 400 mg 2 hours before surgery, then oral pentoxifylline 400 mg three times per day for 4 weeks, while the control group will only take standard of care. The researchers will compare the difference in pain score and time for wound healing relative to the control group.
Interventions
DRUGPentoxifylline
Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continued for four weeks after the surgery. Standard of care for pain management, including paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours.
DRUGparacetamol +ketorolac
Patients receive the usual treatment only: paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult female patients aged 18 to 65 years 2. Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery.
Exclusion criteria
1. Patients on treatment regimen of phosphodiesterase inhibitors 2. Patients who are taking antiplatelet or anticoagulant treatment 3. Patients who are allergic to phosphodiesterase inhibitors 4. History of recent hemorrhagic events 5. Active peptic ulcer 6. History of psychological problems 7. History of chronic pain management 8. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative level of pain | 24 hours after surgery | Postoperative level of pain immediately after the surgery and every 6 hours until 24 hours after surgery using the Numeric Rating Score (NRS) ranging from 0 (indicating no pain) to 10 (expressing the pain as bad as it could possibly be). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of patients need rescue analgesia | 24 hours after surgery | The number of patients need rescue analgesia within 24 hours after surgery |
| Time for wound healing | Within 4 weeks of follow-up after the surgery | The time for removal of surgical sutures |
| The incidence of post-surgical complications | Within 4 weeks of follow-up after the surgery | The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis |
Countries
Egypt
Outcome results
None listed