Pain, PostoperativePhase 4NCT01964781
The Effect of Topical Administration of Common Drugs on Postoperative Bleeding and Pain
A Phase 4 study testing Tranexamic Acid, Bupivacaine and Adrenaline in people with Pain, Postoperative and Postoperative Hemorrhage, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Postoperative Hemorrhage
- What is being tested?
- Tranexamic Acid, Bupivacaine and Adrenaline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral simple mastectomy
- patients undergoing bilateral symmetric breast surgery
Who cannot join
- pregnancy
- A history of former thromboembolic events (to receive TXA)
- cardiovascular disease (to receive adrenaline)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Tranexamic Acid, Bupivacaine, Adrenaline, tranexamic acid plus saline, saline
- Keywords
- Administration, topical, tranexamic acid, adrenaline, bupivacaine, surgery
- Medical subject headings
- Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Topical administration - does it reduce surgical bleeding?
BupivacaineDrug
Also called Marcaine
Topical Bupivacaine- does it reduce surgical pain?
AdrenalineDrug
Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
tranexamic acid plus salineDrug
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| topical tranexamic acid | Experimental | tranexamic acid to be smeared on surgical wounds before closure Receives: Drug: Tranexamic Acid |
| topical adrenaline | Experimental | adrenaline solution to be smeared on surgical wounds before closure Receives: Drug: Adrenaline |
| topical bupivacaine | Experimental | bupivacaine to be smeared on surgical wounds before closure Receives: Drug: Bupivacaine |
| topical adrenaline plus tranexamic acid | Experimental | tranexamic acid and adrenaline to be smeared on surgical wounds before closure Receives: Drug: Tranexamic Acid; Drug: Adrenaline |
| placebo control | Placebo comparator | saline to be smeared on surgical wounds before closure Receives: Drug: saline |
| tranexamic acid and placebo control | Placebo comparator | tranexamic acid and saline to be smeared on surgical wounds before closure Receives: Drug: tranexamic acid plus saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
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
Measured: Measured 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilde Pleym, MD PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964781
- Sponsor's protocol ID
- 2012-004964-23
- Other IDs
- 2012-004964-23
- Status last verified
- May 2019
- First submitted
- 10 Oct 2013
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26349843
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01964781
- Acronym / sponsor ID
- 2012-004964-23
- Conditions
- Pain, Postoperative, Postoperative Hemorrhage
- Keywords
- Administration, topical, tranexamic acid, adrenaline, bupivacaine, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| topical tranexamic acid | Experimental | Drug: Tranexamic Acidtranexamic acid to be smeared on surgical wounds before closure |
| topical adrenaline | Experimental | Drug: Adrenalineadrenaline solution to be smeared on surgical wounds before closure |
| topical bupivacaine | Experimental | Drug: Bupivacainebupivacaine to be smeared on surgical wounds before closure |
| topical adrenaline plus tranexamic acid | Experimental | Drug: Tranexamic Acid, Drug: Adrenalinetranexamic acid and adrenaline to be smeared on surgical wounds before closure |
| placebo control | Placebo comparator | Drug: salinesaline to be smeared on surgical wounds before closure |
| tranexamic acid and placebo control | Placebo comparator | Drug: tranexamic acid plus salinetranexamic acid and saline to be smeared on surgical wounds before closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing unilateral simple mastectomy
- patients undergoing bilateral symmetric breast surgery
Key exclusion criteria (3 listed)
- pregnancy
- A history of former thromboembolic events (to receive TXA)
- cardiovascular disease (to receive adrenaline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidTopical administration - does it reduce surgical bleeding? | Drug | topical adrenaline plus tranexamic acid, topical tranexamic acid |
| BupivacaineAlso: MarcaineTopical Bupivacaine- does it reduce surgical pain? | Drug | topical bupivacaine |
| AdrenalineTopical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid? | Drug | topical adrenaline, topical adrenaline plus tranexamic acid |
| tranexamic acid plus saline | Drug | tranexamic acid and placebo control |
| saline | Drug | placebo control |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Results publication: PubMed 26349843Ausen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde Pleym, MD PhD study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid, Bupivacaine and Adrenaline in people with Pain, Postoperative and Postoperative Hemorrhage, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood on drains postoperatively (time frame: 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.