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

NCT01398982 | Completed Phase 4 Results

• 1 other identifier: 10-0969-A
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transversus Abdominis Plane (TAP) Block Catheter; DIEP or Free MS-TRAM Breast Reconstruction; Local Pain Management; Abdominal/ Donor Site

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Total In-hospital Cumulative Opioid Consumption

  In-patient hospital stay average of 4 - 5 days

• Daily Pain Intensity Scores at Rest and With Movement

  In Hospital postoperative measures, average 4-5 days

• Pain Disability

  Hospital discharge, average 4-5 days, 6 months and 1 year following discharge

• First Bowel Movement

  In-patient hospital stay, average 4-5 days

• Anti-nausea Consumption

  In-patient hospital stay, average 4-5 days

Study Arms (2)

Isotonic saline (control group)

PLACEBO COMPARATOR

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)

Bupivacaine (study group)

EXPERIMENTAL

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: Bupivacaine (study group); Drug: Isotonic saline (control group)

Interventions

Bupivacaine (study group) DRUG

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.

Bupivacaine (study group)

Isotonic saline (control group) DRUG

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.

Bupivacaine (study group); Isotonic saline (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Society of Plastic Surgeons: collaborator
• The Plastic Surgery Foundation: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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.

  PMID: 25347623 RESULT

• 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.

  PMID: 24325953 DERIVED

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride; Control Groups

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

The study limitations include the difficulty in capturing data at all points postoperatively. The repeated measure pain scores at rest and with movement were not recorded for all patients (recorded for 75% at rest and 53% with movement).

Results Point of Contact

• Title: Kate Butler
• Organization: UHN

kbutler@uhnresearch.ca

416-340-4800

Study Officials

• Toni Zhong, MD, MHS

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 21, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 1, 2015
• Results First Posted: April 1, 2015

Record last verified: 2015-03

Locations

CA (1)