Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy

Conditions
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Pain, Postoperative, Breast Cancer

Intervention / Treatment
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* Drug: 40ml of 0.25% bupivacaine
* Drug: 40ml of 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection Exclusion Criteria: Male patients Bilateral breast cancer. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection. Patients with known psychological or mental problems. Patients who were not exposed to axillary dissection

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>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. | Drug: 40ml of 0.25% bupivacaine<br> <br> |
| Placebo Comparator: Placebo<br>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) | Drug: 40ml of 0.9% normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain score | The intensity of pain will be assessed by the VAS score | first 24 hours | 
| Number of demands for analgesic | How many times the patient will require analgesics | First 24 hours | 
| Timing of first demand for analgesic | Time lapse between recovery from surgery and first demand for analgesic | First 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupivacaine, Post-mastectomy acute pain, Wound instillation