Efficacy of US-guided TAP Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap

NCT03699267 | Completed

• 1 other identifier: 88/561
• Study Type: observational
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Breast Reconstruction Surgery; TAP Block; Ultrasound; Analgesia; Efficacy

Outcome Measures

Primary Outcomes (2)

• Fentanyl consumed/administered during intraoperative time

  Based on anaesthesia records, fentanyl administered during intraoperative time was calculated in milligrams per kilogram for each participant.

  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.

  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

  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

  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

  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

  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).

Study Arms (4)

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

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

Other: US-guided Bilateral TAP block

Interventions

US-guided Bilateral TAP block OTHER

M + UBR TRAM / GBA + TAP; UBR TRAM / GBA + TAP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• Instituto Portugues de Oncologia, Francisco Gentil, Porto: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Afonso

  IPO-Porto, E.P.E.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10