Trial Information

The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial

1. 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:

A. 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

B. Repeated measures outcomes

In Hospital postoperative measures:

i. 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

C. 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.