TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT

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

Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Adequate pain control is important as it has been shown to reduce medical complications, in-hospital death, shortens hospital stay, lessen chronic pain and disability, and in turn lower health-care costs. The current postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties, bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral nerve block. Although the TAP block has been found to be an effective pain-relief following major abdominal surgeries, its use has never been studied for breast reconstruction using abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a TAP block in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. This study has significant implications in improving both clinical care and health outcomes in patients undergoing this common method of breast reconstruction technique.

Study Overview

• Status: Completed
• Conditions: Transversus Abdominis Plane (TAP) Block Catheter; DIEP or Free MS-TRAM Breast Reconstruction; Local Pain Management; Abdominal/ Donor Site
• Intervention / Treatment: Drug: Isotonic saline (control group); Drug: Bupivacaine (study group)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

-Pre-operative eligibility:

• Patients above the age of 18, no upper age limit
• English-speaking
• Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
• Reconstruction using abdominal tissues including free MS-TRAM or DIEP

Exclusion Criteria:

• Patient refusal
• Inability to give informed consent
• BMI > 40
• Allergy to Bupivacaine
• Known cardiac or liver disease (contraindicated for Bupivacaine use)

• Patients who will undergo any of the following:

  • Implant breast reconstruction
  • Combined implant and autologous tissue reconstruction
  • Non-abdominally based autologous tissue reconstruction
  • Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)
• Drug addiction
• Opioid tolerance defined as preoperative opioid use of >50 mg PO morphine equivalent
• Psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Isotonic saline (control group); At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.	Drug: Isotonic saline (control group); At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
Experimental: Bupivacaine (study group); At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.	Drug: Isotonic saline (control group); At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.; Drug: Bupivacaine (study group); At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Total Opioid Consumption	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.	first postoperative 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total In-hospital Cumulative Opioid Consumption	Total in-hospital cumulative opioid consumption levels	In-patient hospital stay average of 4 - 5 days
Daily Pain Intensity Scores at Rest and With Movement	Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)	In Hospital postoperative measures, average 4-5 days
Pain Disability	Pain Disability Index Scores	Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
First Bowel Movement	Time to first bowel movement (# of days)	In-patient hospital stay, average 4-5 days
Anti-nausea Consumption	Total in-hospital cumulative anti-nausea consumption	In-patient hospital stay, average 4-5 days
Quality of Recovery	Quality of Recovery (QOR) score (0-18)	In-patient hospital stay, first post operative 48 hours
Duration of Hospital Stay	Duration of hospital stay (# of days)	In-patient hospital stay, average of 4-5 days
Postoperative Nausea and Vomiting	Postoperative nausea and vomiting (score of 0-3)	In Hospital postoperative measures, average 4-5 days
Sedation Level	Sedation score in-patient	In Hospital postoperative measures, average 4-5 days
Pain Frequency and Intensity	Short-form McGill Pain Questionnaire Score	Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Anxiety and Depression	Hospital Anxiety and Depression Scale Score	Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Health Related Quality of Life	Short-form health-related quality of life 36 Scores	Hospital discharge, average 4-5 days, 6 months and 1 year following discharge
Time to Ambulation	Time to ambulation (# of days)	In-patient hospital stay, average 4-5 days

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Plastic Surgery Foundation; Canadian Society of Plastic Surgeons
• Investigators: Principal Investigator: Toni Zhong, MD, MHS, University Health Network, Toronto

Publications and helpful links

General Publications

• Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SOP. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial. Plast Reconstr Surg. 2014 Nov;134(5):870-878. doi: 10.1097/PRS.0000000000000613.
• Zhong T, Ojha M, Bagher S, Butler K, O'Neill AC, McCluskey SA, Clarke H, Hofer SO, Srinivas C. Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Dec 10;14:424. doi: 10.1186/1745-6215-14-424.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 21, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 10-0969-A