Breast Reconstruction SurgeryNCT03699267
Efficacy of US-guided TAP Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap
An observational study of Breast Reconstruction Surgery and TAP Block, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto.
Trial summary
Ultrasound (US)-guided transversus abdominis plane block (TAP) has demonstrated favourable results in lower abdominal surgery. Literature about its efficacy in breast reconstruction surgery with transversus rectus abdominis myocutaneous (TRAM) flap is still scarce. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction Surgery, TAP Block, Ultrasound
- What is being tested?
- US-guided Bilateral TAP block
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2017
- Phase
- Observational
- 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
Study population: Women with age superior to 18 years-old scheduled for unilateral breast reconstruction surgery with TRAM flap or partial/total or totalization mastectomy followed by TRAM reconstruction in the study site.
Who may be able to join
- Patients of age superior 18 years-old;
- Patients scheduled to unilateral breast reconstruction surgery with TRAM flap or partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan was GBA or GBA + TAP.
Who cannot join
- Refusal to participate in study;
- Inability to sign written informed consent;
- Body mass index superior (BMI) 40 kg/m2;
- Opioid tolerance (defined as previous consume, minimum period of 2 months, ≥ 50 mg morphine equivalents, per os);
- Substance abuse (addiction syndrome)
- Renal chronic disease with creatinine clearance < 30 mL/min/1.73m2); hepatic disease (Child-Pugh score of 1, 2 or 3);
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- Patients subjected to other surgeries within the same operative time
- Patients that TAP block was not performed before surgical incision and the dose and volume of ropivacaine wasn't 20 mL, ropivacaine 0.375%
- Patients whose systemic analgesic protocol wasn't that adopted by Anesthesiology Department for this kind of surgery
About this study
Official title: Efficacy of Ultrasound-guided Transversus Abdominis Plane Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap: an Observational Prospective Study
Ultrasound (US)-guided transversus abdominis plane block (TAP) has demonstrated favourable results in lower abdominal surgery. Literature about its efficacy in breast reconstruction surgery with transversus rectus abdominis myocutaneous (TRAM) flap is still scarce.
In the current study investigators pretend to evaluate the efficacy of US-guided bilateral TAP block for unilateral breast reconstruction using autologous abdominal graft in women with breast cancer's history.
Read the detailed description
The investigators led a prospective observational study in patients/participants scheduled to unilateral breast reconstruction surgery with TRAM flap (UBR TRAM) or partial/total or totalization mastectomy followed by TRAM reconstruction (M + UBR TRAM). Participants' anesthetic plan was general balanced anesthesia (GBA) or general balanced anesthesia combined with bilateral TAP block (GBA + TAP).
The anesthetic plan was adopted by the anaesthetist assigned to the operating room on surgery's day. Then, two groups were considered for the study: group submitted to GBA and another submitted to GBA + TAP. Anaesthetic information about intra-operative date was consulted. Investigators included patients subjected to general anesthesia with orotracheal intubation. Intravenous (IV) bolus of fentanyl were administered at anesthetic induction and according to analgesic needs. In patients whose anesthetic plan included TAP block investigators considered cases that it was performed after anesthetic induction before surgical incision. TAP block was performed according to Anesthesiology's Department. After aspiration, a volume of 20 mL ropivacaine 0.375% was administered, bilaterally. Investigators didn´t consider for the study participants whose systemic postoperative analgesic protocol wasn't that adopted by Anesthesiology Department for this kind of surgery.
It was evaluated:
- Intraoperative period: fentanyl consumption (mg/kg), antiemetic prophylaxis and anesthesia duration;
- Post-anaesthesia care unit (PACU): consumed opioids, total score and score relative to consciousness, at admission and discharge, pain assessment, at admission and discharge and nausea and vomiting incidence and stay's length
- After discharge of PACU until 4 hours after surgery's end and between 4th until 24th postoperative hour: morphine consumption, pain assessment, nausea and vomiting incidence and other complications.
- Conditions
- Breast Reconstruction Surgery, TAP Block, Ultrasound, Analgesia, Efficacy
- Being tested
- US-guided Bilateral TAP block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided Bilateral TAP blockOther
| Study group | Role | What they receive |
|---|---|---|
| UBR TRAM / GBA | Patients scheduled for unilateral breast reconstruction surgery with TRAM flap whose anesthetic plan adopted by the anesthetist was general balanced anesthesia | |
| UBR TRAM / GBA + TAP | Patients scheduled for unilateral breast reconstruction surgery with TRAM flap whose anesthetic plan adopted by the anesthetist was general balanced anesthesia combined with US-guided bilateral TAP block Receives: Other: US-guided Bilateral TAP block | |
| M + UBR TRAM / GBA | Patients scheduled for partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan adopted by the anesthetist was general balanced anesthesia | |
| M + UBR TRAM / GBA + TAP | Patients scheduled for partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan adopted by the anesthetist was general balanced anesthesia combined with US-guided bilateral TAP block Receives: Other: US-guided Bilateral TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl consumed/administered during intraoperative time
Based on anaesthesia records, fentanyl administered during intraoperative time was calculated in milligrams per kilogram for each participant.
Measured: Investigators recorded this variable for each participant since the date of start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Morphine consumed/administered during post-anaesthesia care unit stay
Based on post-anaesthesia care unit records, quantity, in milligrams, of supplemental morphine administered to each participant was recorded.
Measured: Investigators recorded this variable for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Secondary outcomes (4)
Morphine consumed/administered after discharge from post-anaesthesia care unit discharge until 24 hours since surgery's end
Based on records from Acute Pain Registration, it was recorded, for each participant, total morphine consumed/administered, in milligrams, since post-anaesthesia care unit's discharge until 4th postoperative hour and since 4th until 24th postoperative hour.
Measured: Investigators recorded this variable for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Pain's assessment at rest and on movement
Evaluation of pain at rest and on movement, using a qualitative scale. Investigators used qualitative pain scale adopted in the study site. Scale ranges from 0 to 4. It is defined as: 0 - no pain reported by participant; 1 - slight pain reported by participant; 2 - moderate pain reported by participant; 3 - severe pain reported by participant and 4 - excruciating pain.
Pain assessment was recorded, based on records from post-anaesthesia care unit and Acute Pain Registration, for each participant at different moments. At admission and discharge from post-anaesthesia care unit, at 4th postoperative hour and at 24th postoperative hour.
Measured: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Recovery score, at admission and discharge from post-anaesthesia care unit, according to post-anaesthesia care unit's discharge criteria
It was registered for each participant, total score at PACU's admission and discharge according to: Peripheral O2 saturation: 0 - < 85%, 1 - 85-95% and 2 - > 95%; Motor activity: 0 - inability to move, 1 - move 2 extremities; 2 - move 4 extremities; Hemodynamic: 0 - variation of medium arterial pressure (MAP) comparing to pre-anaesthetic evaluation > 40 mmHg or hear rate (HR)<40 or >50 bpm; 1 - variation of MAP comparing to pre-anaesthetic evaluation >40 mmHg or HR<50 or >120; 2 - MAP and HR similar to pre-anesthetic evaluation; Temperature: 0 - body temperature (T)<35ºC; 1 - T 35-35.5ºC; 2 - T 35.5-36ºC; Breathing: 0 - no spontaneous breathing; 1 - dyspnea/respiratory rate (RR) <10 or >20; 2 - eupnea; Consciousness: 0 - nor responding to stimuli; 1 - responding to simple questions; 2 - awake and alert; Nausea/Vomiting: 0 - vomiting; 1 - nausea; 2 - no nausea or vomiting; Pain: 0 - intolerable; 1 - intense; 2 - mild; 3 - no pain. Total score was calculated by summing each score.
Measured: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Nausea and vomiting incidence
Based on post-anaesthesia care unit and ward records, it was registered any episodes of nausea or vomiting for each participant until 24th postoperative hour.
Measured: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Luísa Santos Afonso, Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Investigators
- Ana Afonso, Principal investigator, IPO-Porto, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699267
- Sponsor's protocol ID
- 88/561
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Transversus Abdominis Plane Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03699267
- Acronym / sponsor ID
- 88/561
- Conditions
- Breast Reconstruction Surgery, TAP Block, Ultrasound, Analgesia, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, PortoUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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.
Ultrasound (US)-guided transversus abdominis plane block (TAP) has demonstrated favourable results in lower abdominal surgery. Literature about its efficacy in breast reconstruction surgery with transversus rectus abdominis myocutaneous (TRAM) flap is still scarce.
In the current study investigators pretend to evaluate the efficacy of US-guided bilateral TAP block for unilateral breast reconstruction using autologous abdominal graft in women with breast cancer's history.
Detailed description
The investigators led a prospective observational study in patients/participants scheduled to unilateral breast reconstruction surgery with TRAM flap (UBR TRAM) or partial/total or totalization mastectomy followed by TRAM reconstruction (M + UBR TRAM). Participants' anesthetic plan was general balanced anesthesia (GBA) or general balanced anesthesia combined with bilateral TAP block (GBA + TAP).
The anesthetic plan was adopted by the anaesthetist assigned to the operating room on surgery's day. Then, two groups were considered for the study: group submitted to GBA and another submitted to GBA + TAP. Anaesthetic information about intra-operative date was consulted. Investigators included patients subjected to general anesthesia with orotracheal intubation. Intravenous (IV) bolus of fentanyl were administered at anesthetic induction and according to analgesic needs. In patients whose anesthetic plan included TAP block investigators considered cases that it was performed after anesthetic induction before surgical incision. TAP block was performed according to Anesthesiology's Department. After aspiration, a volume of 20 mL ropivacaine 0.375% was administered, bilaterally. Investigators didn´t consider for the study participants whose systemic postoperative analgesic protocol wasn't that adopted by Anesthesiology Department for this kind of surgery.
It was evaluated:
- Intraoperative period: fentanyl consumption (mg/kg), antiemetic prophylaxis and anesthesia duration;
- Post-anaesthesia care unit (PACU): consumed opioids, total score and score relative to consciousness, at admission and discharge, pain assessment, at admission and discharge and nausea and vomiting incidence and stay's length
- After discharge of PACU until 4 hours after surgery's end and between 4th until 24th postoperative hour: morphine consumption, pain assessment, nausea and vomiting incidence and other complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UBR TRAM / GBA | – | –Patients scheduled for unilateral breast reconstruction surgery with TRAM flap whose anesthetic plan adopted by the anesthetist was general balanced anesthesia |
| UBR TRAM / GBA + TAP | – | Other: US-guided Bilateral TAP blockPatients scheduled for unilateral breast reconstruction surgery with TRAM flap whose anesthetic plan adopted by the anesthetist was general balanced anesthesia combined with US-guided bilateral TAP block |
| M + UBR TRAM / GBA | – | –Patients scheduled for partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan adopted by the anesthetist was general balanced anesthesia |
| M + UBR TRAM / GBA + TAP | – | Other: US-guided Bilateral TAP blockPatients scheduled for partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan adopted by the anesthetist was general balanced anesthesia combined with US-guided bilateral TAP block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with age superior to 18 years-old scheduled for unilateral breast reconstruction surgery with TRAM flap or partial/total or totalization mastectomy followed by TRAM reconstruction in the study site.
Key inclusion criteria (2 listed)
- Patients of age superior 18 years-old;
- Patients scheduled to unilateral breast reconstruction surgery with TRAM flap or partial/total or totalization mastectomy followed by TRAM reconstruction whose anesthetic plan was GBA or GBA + TAP.
Key exclusion criteria (9 listed)
- Refusal to participate in study;
- Inability to sign written informed consent;
- Body mass index superior (BMI) 40 kg/m2;
- Opioid tolerance (defined as previous consume, minimum period of 2 months, ≥ 50 mg morphine equivalents, per os);
- Substance abuse (addiction syndrome)
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 |
|---|---|---|
| US-guided Bilateral TAP block | Other | M + UBR TRAM / GBA + TAP, UBR TRAM / GBA + TAP |
Primary outcome
Fentanyl consumed/administered during intraoperative time
Time frame: Investigators recorded this variable for each participant since the date of start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Based on anaesthesia records, fentanyl administered during intraoperative time was calculated in milligrams per kilogram for each participant.
Morphine consumed/administered during post-anaesthesia care unit stay
Time frame: Investigators recorded this variable for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Based on post-anaesthesia care unit records, quantity, in milligrams, of supplemental morphine administered to each participant was recorded.
4 secondary outcomes
Morphine consumed/administered after discharge from post-anaesthesia care unit discharge until 24 hours since surgery's end
Time frame: Investigators recorded this variable for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Pain's assessment at rest and on movement
Time frame: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Recovery score, at admission and discharge from post-anaesthesia care unit, according to post-anaesthesia care unit's discharge criteria
Time frame: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
Nausea and vomiting incidence
Time frame: Investigators recorded these variables for each participant since the start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).
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 9 Oct 2018.
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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.
Ana Afonso principal investigator
IPO-Porto, E.P.E.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction Surgery and TAP Block, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto.
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 9 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fentanyl consumed/administered during intraoperative time (time frame: Investigators recorded this variable for each participant since the date of start of the study until its end (since April 2015 until June 2017, 2 years and 2 months). Outcome was globally evaluated for each cohort at the end of the study (June 2017).). 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?
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 9 Oct 2018.