Pain, Postoperative, Postoperative Hemorrhage
Conditions
Keywords
Administration, topical, tranexamic acid, adrenaline, bupivacaine, surgery
Brief summary
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
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.
Interventions
Topical administration - does it reduce surgical bleeding?
Topical Bupivacaine- does it reduce surgical pain?
Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of pain in operated breast | Measured 24 hours postoperatively | Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively |
| Amount of blood on drains postoperatively | 24 hours postoperatively | Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours. |
Countries
Norway