Breast Cancer, Pain, Postoperative
Conditions
Keywords
bupivacaine, Post-mastectomy acute pain, Wound instillation
Brief summary
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
Detailed description
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
Interventions
DRUG40ml of 0.25% bupivacaine
DRUG40ml of 0.9% normal saline
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
Exclusion criteria
1. Male patients 2. Bilateral breast cancer. 3. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse 4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection. 5. Patients with known psychological or mental problems. 6. Patients who were not exposed to axillary dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue pain score | first 24 hours | The intensity of pain will be assessed by the VAS score |
| Number of demands for analgesic | First 24 hours | How many times the patient will require analgesics |
| Timing of first demand for analgesic | First 24 hours | Time lapse between recovery from surgery and first demand for analgesic |
Countries
Egypt
Outcome results
None listed