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

NCT ID: NCT01964781

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Pain, Postoperative; Postoperative Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

topical tranexamic acid

tranexamic acid to be smeared on surgical wounds before closure

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Topical administration - does it reduce surgical bleeding?

topical adrenaline

adrenaline solution to be smeared on surgical wounds before closure

Group Type: EXPERIMENTAL

Adrenaline

Intervention Type: DRUG

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

topical bupivacaine

bupivacaine to be smeared on surgical wounds before closure

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Topical Bupivacaine- does it reduce surgical pain?

topical adrenaline plus tranexamic acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Topical administration - does it reduce surgical bleeding?

Adrenaline

Intervention Type: DRUG

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

placebo control

saline to be smeared on surgical wounds before closure

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: DRUG

tranexamic acid and placebo control

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

Group Type: PLACEBO_COMPARATOR

tranexamic acid plus saline

Intervention Type: DRUG

Interventions

Tranexamic Acid

Topical administration - does it reduce surgical bleeding?

Intervention Type: DRUG

Bupivacaine

Topical Bupivacaine- does it reduce surgical pain?

Intervention Type: DRUG

Adrenaline

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

Intervention Type: DRUG

tranexamic acid plus saline

Intervention Type: DRUG

saline

Intervention Type: DRUG

Other Intervention Names

Marcaine

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilde Pleym, MD PhD

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

St Olavs University Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 26349843 (View on PubMed)

Other Identifiers

2012-004964-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012-004964-23

Identifier Type: -

Identifier Source: org_study_id