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

Primary Purpose

Pain, Postoperative, Postoperative Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Tranexamic Acid
Bupivacaine
Adrenaline
tranexamic acid plus saline
saline
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Administration, topical, tranexamic acid, adrenaline, bupivacaine, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • St Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

topical tranexamic acid

topical adrenaline

topical bupivacaine

topical adrenaline plus tranexamic acid

placebo control

tranexamic acid and placebo control

Arm Description

tranexamic acid to be smeared on surgical wounds before closure

adrenaline solution to be smeared on surgical wounds before closure

bupivacaine to be smeared on surgical wounds before closure

tranexamic acid and adrenaline to be smeared on surgical wounds before closure

saline to be smeared on surgical wounds before closure

tranexamic acid and saline to be smeared on surgical wounds before closure

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 10, 2013
Last Updated
May 16, 2019
Sponsor
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01964781
Brief Title
The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Hemorrhage
Keywords
Administration, topical, tranexamic acid, adrenaline, bupivacaine, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical tranexamic acid
Arm Type
Experimental
Arm Description
tranexamic acid to be smeared on surgical wounds before closure
Arm Title
topical adrenaline
Arm Type
Experimental
Arm Description
adrenaline solution to be smeared on surgical wounds before closure
Arm Title
topical bupivacaine
Arm Type
Experimental
Arm Description
bupivacaine to be smeared on surgical wounds before closure
Arm Title
topical adrenaline plus tranexamic acid
Arm Type
Experimental
Arm Description
tranexamic acid and adrenaline to be smeared on surgical wounds before closure
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
saline to be smeared on surgical wounds before closure
Arm Title
tranexamic acid and placebo control
Arm Type
Placebo Comparator
Arm Description
tranexamic acid and saline to be smeared on surgical wounds before closure
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Topical administration - does it reduce surgical bleeding?
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Topical Bupivacaine- does it reduce surgical pain?
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Intervention Description
Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
Intervention Type
Drug
Intervention Name(s)
tranexamic acid plus saline
Intervention Type
Drug
Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
Amount of blood on drains postoperatively
Description
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours.
Time Frame
24 hours postoperatively
Title
Amount of pain in operated breast
Description
Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively
Time Frame
Measured 24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Pleym, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26349843
Citation
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.
Results Reference
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The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain

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