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

St. Olavs Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Hemorrhage; Pain, Postoperative

Treatments: Drug: Tranexamic Acid; Drug: Adrenaline; Drug: Bupivacaine; Drug: tranexamic acid plus saline; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01964781

2012-004964-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups, including a placebo group

topical tranexamic acid

Experimental group

Description:

tranexamic acid to be smeared on surgical wounds before closure

Treatment:

Drug: Tranexamic Acid

topical adrenaline

Experimental group

Description:

adrenaline solution to be smeared on surgical wounds before closure

Treatment:

Drug: Adrenaline

topical bupivacaine

Experimental group

Description:

bupivacaine to be smeared on surgical wounds before closure

Treatment:

Drug: Bupivacaine

topical adrenaline plus tranexamic acid

Experimental group

Description:

tranexamic acid and adrenaline to be smeared on surgical wounds before closure

Treatment:

Drug: Adrenaline

Drug: Tranexamic Acid

placebo control

Placebo Comparator group

Description:

saline to be smeared on surgical wounds before closure

Treatment:

Drug: saline

tranexamic acid and placebo control

Placebo Comparator group

Description:

tranexamic acid and saline to be smeared on surgical wounds before closure

Treatment:

Drug: tranexamic acid plus saline