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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964781
• Other study ID #: 2012-004964-23
• Secondary ID: 2012-004964-23
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Hemorrhage
• Pain, Postoperative
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid
Topical administration - does it reduce surgical bleeding?
• Bupivacaine
Topical Bupivacaine- does it reduce surgical pain?
• Adrenaline
Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
• tranexamic acid plus saline

• saline

Locations

Country	Name	City	State
Norway	St Olavs University Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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