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

Sponsor

St. Olavs Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01964781

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Postoperative Hemorrhage	Drug: Tranexamic Acid Drug: Bupivacaine Drug: Adrenaline Drug: tranexamic acid plus saline Drug: saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: topical tranexamic acid tranexamic acid to be smeared on surgical wounds before closure	Drug: Tranexamic Acid Topical administration - does it reduce surgical bleeding?
Experimental: topical adrenaline adrenaline solution to be smeared on surgical wounds before closure	Drug: Adrenaline Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
Experimental: topical bupivacaine bupivacaine to be smeared on surgical wounds before closure	Drug: Bupivacaine Topical Bupivacaine- does it reduce surgical pain? Other Names: Marcaine
Experimental: topical adrenaline plus tranexamic acid tranexamic acid and adrenaline to be smeared on surgical wounds before closure	Drug: Tranexamic Acid Topical administration - does it reduce surgical bleeding? Drug: Adrenaline Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
Placebo Comparator: placebo control saline to be smeared on surgical wounds before closure	Drug: saline
Placebo Comparator: tranexamic acid and placebo control tranexamic acid and saline to be smeared on surgical wounds before closure	Drug: tranexamic acid plus saline

Outcome Measures

Primary Outcome Measures

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