Clinical trial NCT01964781: The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Hemorrhage
Keywords: Administration, topical
tranexamic acid
adrenaline
bupivacaine
surgery
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Amount of blood on drains postoperatively
timeFrame: 24 hours postoperatively
measure: Amount of pain in operated breast
timeFrame: Measured 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Hilde Pleym, MD PhD
role: STUDY_DIRECTOR
References:
citation: Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.