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

This study has been completed.
Sponsor:
Collaborators:
Canadian Society of Plastic Surgeons
Plastic Surgery Educational Foundation
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01398982
First received: July 18, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Transversus Abdominis Plane (TAP) Block Catheter
DIEP or Free MS-TRAM Breast Reconstruction
Local Pain Management
Abdominal/ Donor Site
Drug: Bupivacaine (study group)
Drug: Isotonic saline (control group)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Transversus Abdominis Plane (TAP) Block in Autologous Breast Reconstruction Donor Site: A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Mean total opioid consumption [ Time Frame: first postoperative 48 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total in-hospital cumulative opioid consumption [ Time Frame: In-patient hospital stay average of 4 - 5 days ] [ Designated as safety issue: No ]
    Total in-hospital cumulative opioid consumption

  • Daily pain intensity scores at rest and with movement [ Time Frame: In Hospital postoperative measures, average 4-5 days ] [ Designated as safety issue: No ]
    Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)

  • Pain disability [ Time Frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge ] [ Designated as safety issue: No ]
    Pain Disability Index Scores

  • First bowel movement [ Time Frame: In-patient hospital stay, average 4-5 days ] [ Designated as safety issue: No ]
    Time to first bowel movement (# of days)

  • Anti-nausea consumption [ Time Frame: In-patient hospital stay, average 4-5 days ] [ Designated as safety issue: No ]
    Total in-hospital cumulative anti-nausea consumption

  • Quality of Recovery [ Time Frame: In-patient hospital stay, first post operative 48 hours ] [ Designated as safety issue: No ]
    Quality of Recovery (QOR) score (0-18)

  • Duration of hospital stay [ Time Frame: In-patient hospital stay, average of 4-5 days ] [ Designated as safety issue: No ]
    Duration of hospital stay (# of days)

  • Postoperative nausea and vomiting [ Time Frame: In Hospital postoperative measures, average 4-5 days ] [ Designated as safety issue: No ]
    Postoperative nausea and vomiting (score of 0-3)

  • Sedation level [ Time Frame: In Hospital postoperative measures, average 4-5 days ] [ Designated as safety issue: No ]
    Sedation score

  • Pain frequency and intensity [ Time Frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge ] [ Designated as safety issue: No ]
    Short-form McGill Pain Questionnaire Score

  • Anxiety and Depression [ Time Frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale Score

  • Health related Quality of Life [ Time Frame: Hospital discharge, average 4-5 days, 6 months and 1 year following discharge ] [ Designated as safety issue: No ]
    Short-form 36 Scores

  • Time to ambulation [ Time Frame: In-patient hospital stay, average 4-5 days ] [ Designated as safety issue: No ]
    Time to ambulation (# of days)


Enrollment: 93
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Isotonic saline (control group)
At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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 or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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 or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398982

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Society of Plastic Surgeons
Plastic Surgery Educational Foundation
Investigators
Principal Investigator: Toni Zhong, MD, MHS University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01398982     History of Changes
Other Study ID Numbers: 10-0969-A
Study First Received: July 18, 2011
Last Updated: February 10, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014