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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 P

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 Summary: 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.
Sponsor: St. Olavs Hospital

Current Primary Outcome:

• Amount of blood on drains postoperatively [ Time Frame: 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.
• Amount of pain in operated breast [ Time Frame: Measured 24 hours postoperatively ]
  Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Olavs Hospital

Dates:
Date Received: October 10, 2013
Date Started: August 2013
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017