Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction

July 6, 2016 updated by: Chester Mays

Abdominal Wall Reconstruction: Postoperative Outcomes Using Transverse Abdominal Plane Anesthesia

The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal wall reconstruction population using an intraoperative local anesthetic infusion. A prospective randomized double blind study of patients undergoing component separation will be performed in order to assess the following outcomes:

  1. Length of Stay (LOS)
  2. Return of bowel function
  3. Narcotic pain medication requirements
  4. Nausea and emesis
  5. Pain scores

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

One group will be the control group (group A) and the other will be the study group (group B). Neither patient nor physician will know which group they have been assigned. Informed consent will be obtained during pre-operative evaluation in the clinic prior to the day of surgery as stated above. Relevant medical history will be entered into a secure database. Information collected will include patient demographics, medical co-morbidities, history of prior procedures, preoperative pain scores, postoperative nausea, emesis, pain scores, dermatomal anesthesia, adjuvant narcotic usage, return of bowel function and length of stay (LOS).

Patients will be randomly separated into 2 groups at the time of surgery through the randomization log of the investigational drug service (IDS) pharmacy. At the request of the attending surgeon a solution will be prepared and delivered to the operating room in a blinded fashion concealed within a shielded vial.

During the abdominal component separation, dissection of the tissue planes housing the sensory fibers will be exposed to allow insertion of a large spinal needle under direct visualization on each side of the abdominal wall. Depending on the study group, the attending surgeon will inject an unknown solution (solution A or B) of either 30ml of Exparel ((bupivacaine liposome injectable suspension) 1.3% ( 13.3mg/ml)). The final test solution will be prepared in the IDS pharmacy by adding a 20 mL Exparel vial and 40cc of normal saline for a total of 60cc with a bupivacaine concentration of 0.44%. This will then be split into two 30cc solutions to be injected into each side of the transverse abdominal plane. A patient in the placebo group will be injected with 30cc of Normal Saline into the TAP region on each side of the abdomen.

All patients, independent of their study group will be provided with Patient Controlled Analgesics (PCA) using Hydromorphone or orally dosed narcotic/acetaminophen combo analgesics to ensure adequate post-operative pain control. The pain scores, dermatomal level of anesthesia, nausea, emesis, return of bowel function and length of stay will be logged into the electronic medical record. Once data collection is complete the groups will be revealed and all of the data will undergo statistical analysis.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects to be included are all competent patients, 18 years of age or older, who undergo abdominal component separation for a hernia.

Exclusion Criteria:

  • Patients who are not having abdominal component separation or are receiving another form of regional anesthesia will be excluded.
  • Patients younger than 18 years of age will be excluded.
  • Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver.
  • Patients' with hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations and will therefore be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EXPAREL
Bilateral, one time injections using 30ml of EXPAREL ((bupivacaine liposome injectable suspension) 1.3% ( 13.3mg/ml)) into the transverse abdominal plane at the time of abdominal component separation. A total of 60cc used with a Bupivacaine concentration of 0.44%.
Drug: EXPAREL
Other Names:
  • bupivacaine liposome injectable suspension
Placebo Comparator: Normal Saline
Bilateral, one time injections of 30ml normal saline into the transverse abdominal plane at the time of abdominal component separation.
Drug: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
determine the length of hospital stay after surgery
participants will be followed for the duration of hospital stay, an expected average of 1 week
postoperative nausea
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
evaluate the presence or absence of postoperative nausea
participants will be followed for the duration of hospital stay, an expected average of 1 week
postoperative emesis
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
evaluate for the presence or absence of postoperative emesis
participants will be followed for the duration of hospital stay, an expected average of 1 week
postoperative return of bowel function
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
record when bowel function returns following surgery
participants will be followed for the duration of hospital stay, an expected average of 1 week
postoperative pain score
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
assess pain score 0-10 a various time points following surgery
participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adjunct narcotic pain medication use
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
quantify the amount of adjunct narcotic pain medication used following surgery to indirectly assess pain control obtained from the TAP block
participants will be followed for the duration of hospital stay, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chester Mays

Investigators

  • Principal Investigator: Howard N Langstein, MD, University of Rochester Division of Plastic and Reconstructive Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00042032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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