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NCT Number: NCT01964781

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

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.

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Key information

Conditions

Pain, Postoperative Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St Olavs University Hospital

Trondheim, 7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

Topical administration - does it reduce surgical bleeding?

Bupivacaine

Drug

Topical Bupivacaine- does it reduce surgical pain?

Other names: Marcaine

Adrenaline

Drug

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

tranexamic acid plus saline

Drug

Saline

Drug

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2013
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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