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

Phase 4

Completed

• Conditions: Postoperative Hemorrhage; Pain, Postoperative
• Interventions: Drug: Bupivacaine; Drug: saline; Drug: tranexamic acid plus saline; Drug: Tranexamic Acid; Drug: Adrenaline

• Registration Number: NCT01964781
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
topical bupivacaine	Bupivacaine	bupivacaine to be smeared on surgical wounds before closure
placebo control	saline	saline to be smeared on surgical wounds before closure
tranexamic acid and placebo control	tranexamic acid plus saline	tranexamic acid and saline to be smeared on surgical wounds before closure
topical tranexamic acid	Tranexamic Acid	tranexamic acid to be smeared on surgical wounds before closure
topical adrenaline	Adrenaline	adrenaline solution to be smeared on surgical wounds before closure
topical adrenaline plus tranexamic acid	Tranexamic Acid	tranexamic acid and adrenaline to be smeared on surgical wounds before closure
topical adrenaline plus tranexamic acid	Adrenaline	tranexamic acid and adrenaline to be smeared on surgical wounds before closure

Primary Outcome Measures

Name	Time	Method
Amount of blood on drains postoperatively	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	Measured 24 hours postoperatively	Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively

Trial Locations

Locations (1)

St Olavs University Hospital; 🇳🇴 Trondheim, Norway