Clinical trial NCT03699267: Efficacy of US-guided TAP Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap
Official title: Efficacy of Ultrasound-guided Transversus Abdominis Plane Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction Surgery
TAP Block
Ultrasound
Analgesia
Efficacy
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fentanyl consumed/administered during intraoperative time
timeFrame: 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).
measure: Morphine consumed/administered during post-anaesthesia care unit stay
timeFrame: 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:
measure: Morphine consumed/administered after discharge from post-anaesthesia care unit discharge until 24 hours since surgery's end
timeFrame: 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).
measure: Pain's assessment at rest and on movement
timeFrame: 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).
measure: Recovery score, at admission and discharge from post-anaesthesia care unit, according to post-anaesthesia care unit's discharge criteria
timeFrame: 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).
measure: Nausea and vomiting incidence
timeFrame: 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).
Other outcomes:
Locations:
Study officials:
affiliation: IPO-Porto, E.P.E.
name: Ana Afonso
role: PRINCIPAL_INVESTIGATOR
References: