The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain

Study Overview
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Brief Summary
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After surgical procedures, interventions to reduce postoperative pain and bleeding are of great importance. In this study, the effect will be investigated of smearing common drugs, which are designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. Although beneficial effects of such an easy and low-cost intervention would be expected, the investigators have found no previous reports on blinded and controlled studies.

Detailed Description
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The drugs to be studied on whether they reduce bleeding are adrenaline (constricts blood vessels) and tranexamic acid (TXA) (prevents bloodclots from dissolving). The drug studied to what extent it reduces pain will be bupivacaine, a common local anaesthetic. Patients undergoing bilateral symmetric breast surgery or single sided mastectomies are candidates for enrollment in the study. The bilateral patients will have two identical procedures and hence two identical wounds in the same patient. This enables the investigators to use one side as control and hence design our study arms as prospective and placebo-controlled. The patients undergoing a one-sided procedure will need to be compared to similar patients, but as wounds will be of different sizes and in different people, larger groups are needed to find significant differences between treatment and controls.

Official Title
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The Effect of Topical Administration of Tranexamic Acid, Adrenaline and Bupivacain on Postoperative Bleeding and Pain in Patients Undergoing Breast Surgery. A Four-armed Placebo-controlled Double Blinded Randomized Study

Conditions
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Pain, Postoperative, Postoperative Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Bupivacaine
* Drug: Adrenaline
* Drug: tranexamic acid plus saline
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral simple mastectomy patients undergoing bilateral symmetric breast surgery Exclusion Criteria: pregnancy A history of former thromboembolic events (to receive TXA) cardiovascular disease (to receive adrenaline)

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical tranexamic acid<br>tranexamic acid to be smeared on surgical wounds before closure | Drug: Tranexamic Acid<br>* Topical administration - does it reduce surgical bleeding?<br>|
| Experimental: topical adrenaline<br>adrenaline solution to be smeared on surgical wounds before closure | Drug: Adrenaline<br>* Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?<br>|
| Experimental: topical bupivacaine<br>bupivacaine to be smeared on surgical wounds before closure | Drug: Bupivacaine<br>* Topical Bupivacaine- does it reduce surgical pain?<br>* Other names: Marcaine;|
| Experimental: topical adrenaline plus tranexamic acid<br>tranexamic acid and adrenaline to be smeared on surgical wounds before closure | Drug: Tranexamic Acid<br>* Topical administration - does it reduce surgical bleeding?<br>Drug: Adrenaline<br>* Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?<br>|
| Placebo Comparator: placebo control<br>saline to be smeared on surgical wounds before closure | Drug: saline<br> <br> |
| Placebo Comparator: tranexamic acid and placebo control<br>tranexamic acid and saline to be smeared on surgical wounds before closure | Drug: tranexamic acid plus saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood on drains postoperatively | Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours. | 24 hours postoperatively | 
| Amount of pain in operated breast | Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively | Measured 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Administration, topical, tranexamic acid, adrenaline, bupivacaine