Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03699267
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2018-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of US-guided TAP Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap
Sponsor:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Organization:
Study Overview
Official Title:
Efficacy of Ultrasound-guided Transversus Abdominis Plane Block in Breast Reconstruction Surgery With Abdominal Myocutaneous Flap: an Observational Prospective Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: