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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01964781
Enrollment
30
Registered
2013-10-17
Start date
2013-08-31
Completion date
2014-12-31
Last updated
2019-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Postoperative Hemorrhage

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

DRUGTranexamic Acid

Topical administration - does it reduce surgical bleeding?

DRUGBupivacaine

Topical Bupivacaine- does it reduce surgical pain?

DRUGAdrenaline

Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?

DRUGtranexamic acid plus saline
DRUGsaline

Sponsors

St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Amount of pain in operated breastMeasured 24 hours postoperativelyEvaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively
Amount of blood on drains postoperatively24 hours postoperativelyDrains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026