Transversus Abdominis Plane (TAP) Block CatheterPhase 4NCT01398982
TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
A Phase 4 study testing Bupivacaine (study group) in people with Transversus Abdominis Plane (TAP) Block Catheter and DIEP or Free MS-TRAM Breast Reconstruction, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management
- What is being tested?
- Bupivacaine (study group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- -Pre-operative eligibility:
- Patients above the age of 18, no upper age limit
- English-speaking
- Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
- Reconstruction using abdominal tissues including free MS-TRAM or DIEP
Who cannot join
- Patient refusal
- Inability to give informed consent
- BMI > 40
- Allergy to Bupivacaine
- Known cardiac or liver disease (contraindicated for Bupivacaine use)
- Patients who will undergo any of the following:
Show all 13Show fewer
- Implant breast reconstruction
- Combined implant and autologous tissue reconstruction
- Non-abdominally based autologous tissue reconstruction
- Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)
- Drug addiction
- Opioid tolerance defined as preoperative opioid use of >50 mg PO morphine equivalent
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Adequate pain control is important as it has been shown to reduce medical complications, in-hospital death, shortens hospital stay, lessen chronic pain and disability, and in turn lower health-care costs. The current postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties, bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral nerve block. Although the TAP block has been found to be an effective pain-relief following major abdominal surgeries, its use has never been studied for breast reconstruction using abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a TAP block in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. This study has significant implications in improving both clinical care and health outcomes in patients undergoing this common method of breast reconstruction technique.
Read the detailed description
- Statement of Objectives/Specific Aims
The transversus abdominis plane (TAP) block is a newly developed block involving T6-L1 nerves that supply the anterior abdominal wall. Its effectiveness has been reported following major abdominal surgeries, but not following abdominally-based autologous tissue breast reconstruction. Thus, we propose a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TAP block in improving pain symptomatology following abdominally-based, autologous tissue breast reconstruction.
The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.
The secondary outcomes of interest are to compare the following parameters:
- Continuous outcomes i. Total in-hospital cumulative opioid consumption ii. Total in-hospital cumulative anti-nausea consumption iii. Quality of Recovery (QOR) score (0-18) iv. Duration of hospital stay
- Repeated measures outcomes
In Hospital postoperative measures:
- Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10) ii. Postoperative nausea and vomiting (score of 0-3) iii. Sedation score
Long-term chronic pain, anxiety, function, and quality of life (QOL) measures:
iv. Pain disability index v. Short-form McGill Pain Questionnaire vi. Hospital Anxiety and Depression Scale vii. Short-form 36
- Time to event outcomes i. Time to first bowel movement ii. Time to ambulation
Hypothesis: Compared to the control group, the TAP block group will have a statistically significant reduction in total in-hospital consumption of opioids, pain scores and side-effects from opioid use such as sedation, nausea, and vomiting. This should also result in a greater QOR score in the TAP block group. Surgical milestones such as time to ambulation, first bowel movement, and duration of hospital stay will also be reduced in the TAP block group. In addition, we hypothesize less acute postoperative pain achieved using the TAP block will result in a reduction in chronic pain and disability, anxiety and depression, and improved QOL in the long-term.
- Conditions
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management, Abdominal/ Donor Site
- Being tested
- Bupivacaine (study group), Isotonic saline (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine (study group)Drug
At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
Isotonic saline (control group)Drug
At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic saline (control group) | Placebo comparator | At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. Receives: Drug: Isotonic saline (control group) |
| Bupivacaine (study group) | Experimental | At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. Receives: Drug: Bupivacaine (study group); Drug: Isotonic saline (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Opioid Consumption
The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.
Measured: first postoperative 48 hours
Secondary outcomes (13)
Total In-hospital Cumulative Opioid Consumption
Total in-hospital cumulative opioid consumption levels
Measured: In-patient hospital stay average of 4 - 5 days
Daily Pain Intensity Scores at Rest and With Movement
Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)
Measured: In Hospital postoperative measures, average 4-5 days
Pain Disability
Pain Disability Index Scores
Measured: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
First Bowel Movement
Time to first bowel movement (# of days)
Measured: In-patient hospital stay, average 4-5 days
Anti-nausea Consumption
Total in-hospital cumulative anti-nausea consumption
Measured: In-patient hospital stay, average 4-5 days
Quality of Recovery
Quality of Recovery (QOR) score (0-18)
Measured: In-patient hospital stay, first post operative 48 hours
Duration of Hospital Stay
Duration of hospital stay (# of days)
Measured: In-patient hospital stay, average of 4-5 days
Postoperative Nausea and Vomiting
Postoperative nausea and vomiting (score of 0-3)
Measured: In Hospital postoperative measures, average 4-5 days
Sedation Level
Sedation score in-patient
Measured: In Hospital postoperative measures, average 4-5 days
Pain Frequency and Intensity
Short-form McGill Pain Questionnaire Score
Measured: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Anxiety and Depression
Hospital Anxiety and Depression Scale Score
Measured: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Health Related Quality of Life
Short-form health-related quality of life 36 Scores
Measured: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Time to Ambulation
Time to ambulation (# of days)
Measured: In-patient hospital stay, average 4-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transversus Abdominis Plane (TAP) Block CatheterStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Society of Plastic Surgeons, The Plastic Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- Toni Zhong, MD, MHS, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398982
- Sponsor's protocol ID
- 10-0969-A
- Status last verified
- Mar 2015
- First submitted
- 18 Jul 2011
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SOP. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial. Plast Reconstr Surg. 2014 Nov;134(5):870-878. doi: 10.1097/PRS.0000000000000613.
PubMed 25347623Zhong T, Ojha M, Bagher S, Butler K, O'Neill AC, McCluskey SA, Clarke H, Hofer SO, Srinivas C. Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Dec 10;14:424. doi: 10.1186/1745-6215-14-424.
PubMed 24325953
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01398982
- Acronym / sponsor ID
- 10-0969-A
- Conditions
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management, Abdominal/ Donor Site
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Society of Plastic Surgeons, The Plastic Surgery Foundation
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Posted 1 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Adequate pain control is important as it has been shown to reduce medical complications, in-hospital death, shortens hospital stay, lessen chronic pain and disability, and in turn lower health-care costs. The current postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties, bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral nerve block. Although the TAP block has been found to be an effective pain-relief following major abdominal surgeries, its use has never been studied for breast reconstruction using abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a TAP block in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. This study has significant implications in improving both clinical care and health outcomes in patients undergoing this common method of breast reconstruction technique.
Detailed description
- Statement of Objectives/Specific Aims
The transversus abdominis plane (TAP) block is a newly developed block involving T6-L1 nerves that supply the anterior abdominal wall. Its effectiveness has been reported following major abdominal surgeries, but not following abdominally-based autologous tissue breast reconstruction. Thus, we propose a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TAP block in improving pain symptomatology following abdominally-based, autologous tissue breast reconstruction.
The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.
The secondary outcomes of interest are to compare the following parameters:
- Continuous outcomes i. Total in-hospital cumulative opioid consumption ii. Total in-hospital cumulative anti-nausea consumption iii. Quality of Recovery (QOR) score (0-18) iv. Duration of hospital stay
- Repeated measures outcomes
In Hospital postoperative measures:
- Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10) ii. Postoperative nausea and vomiting (score of 0-3) iii. Sedation score
Long-term chronic pain, anxiety, function, and quality of life (QOL) measures:
iv. Pain disability index v. Short-form McGill Pain Questionnaire vi. Hospital Anxiety and Depression Scale vii. Short-form 36
- Time to event outcomes i. Time to first bowel movement ii. Time to ambulation
Hypothesis: Compared to the control group, the TAP block group will have a statistically significant reduction in total in-hospital consumption of opioids, pain scores and side-effects from opioid use such as sedation, nausea, and vomiting. This should also result in a greater QOR score in the TAP block group. Surgical milestones such as time to ambulation, first bowel movement, and duration of hospital stay will also be reduced in the TAP block group. In addition, we hypothesize less acute postoperative pain achieved using the TAP block will result in a reduction in chronic pain and disability, anxiety and depression, and improved QOL in the long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline (control group) | Placebo comparator | Drug: Isotonic saline (control group)At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. |
| Bupivacaine (study group) | Experimental | Drug: Bupivacaine (study group), Drug: Isotonic saline (control group)At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above the age of 18, no upper age limit
- English-speaking
- Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
- Reconstruction using abdominal tissues including free MS-TRAM or DIEP
Key exclusion criteria (13 listed)
- Patient refusal
- Inability to give informed consent
- BMI > 40
- Allergy to Bupivacaine
- Known cardiac or liver disease (contraindicated for Bupivacaine use)
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 |
|---|---|---|
| Bupivacaine (study group)At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. | Drug | Bupivacaine (study group) |
| Isotonic saline (control group)At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off. | Drug | Bupivacaine (study group), Isotonic saline (control group) |
Primary outcome
Mean Total Opioid Consumption
Time frame: first postoperative 48 hours
The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.
13 secondary outcomes
Total In-hospital Cumulative Opioid Consumption
Time frame: In-patient hospital stay average of 4 - 5 days
Daily Pain Intensity Scores at Rest and With Movement
Time frame: In Hospital postoperative measures, average 4-5 days
Pain Disability
Time frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
First Bowel Movement
Time frame: In-patient hospital stay, average 4-5 days
Anti-nausea Consumption
Time frame: In-patient hospital stay, average 4-5 days
Quality of Recovery
Time frame: In-patient hospital stay, first post operative 48 hours
Duration of Hospital Stay
Time frame: In-patient hospital stay, average of 4-5 days
Postoperative Nausea and Vomiting
Time frame: In Hospital postoperative measures, average 4-5 days
Sedation Level
Time frame: In Hospital postoperative measures, average 4-5 days
Pain Frequency and Intensity
Time frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Anxiety and Depression
Time frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Health Related Quality of Life
Time frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Time to Ambulation
Time frame: In-patient hospital stay, average 4-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25347623Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SOP. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial. Plast Reconstr Surg. 2014 Nov;134(5):870-878. doi: 10.1097/PRS.0000000000000613.
- Derived from this study: PubMed 24325953Zhong T, Ojha M, Bagher S, Butler K, O'Neill AC, McCluskey SA, Clarke H, Hofer SO, Srinivas C. Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Dec 10;14:424. doi: 10.1186/1745-6215-14-424.
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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.
Toni Zhong, MD, MHS principal investigator
University Health Network, Toronto
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 Bupivacaine (study group) in people with Transversus Abdominis Plane (TAP) Block Catheter and DIEP or Free MS-TRAM Breast Reconstruction, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 13 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 1 Apr 2015. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Total Opioid Consumption (time frame: first postoperative 48 hours). 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 NCT01398982, which also lists 2 linked publications.
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 1 Apr 2015.