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Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction

Primary Purpose

Hernia, Ventral

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EXPAREL
Normal Saline
Sponsored by
Chester Mays
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring length of stay, nausea, emesis, bowel function, pain scores, narcotic pain medication, post operative period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EXPAREL

Normal Saline

Arm Description

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%.

Bilateral, one time injections of 30ml normal saline into the transverse abdominal plane at the time of abdominal component separation.

Outcomes

Primary Outcome Measures

length of stay
determine the length of hospital stay after surgery
postoperative nausea
evaluate the presence or absence of postoperative nausea
postoperative emesis
evaluate for the presence or absence of postoperative emesis
postoperative return of bowel function
record when bowel function returns following surgery
postoperative pain score
assess pain score 0-10 a various time points following surgery

Secondary Outcome Measures

adjunct narcotic pain medication use
quantify the amount of adjunct narcotic pain medication used following surgery to indirectly assess pain control obtained from the TAP block

Full Information

First Posted
October 8, 2014
Last Updated
July 6, 2016
Sponsor
Chester Mays
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1. Study Identification

Unique Protocol Identification Number
NCT02274077
Brief Title
Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction
Official Title
Abdominal Wall Reconstruction: Postoperative Outcomes Using Transverse Abdominal Plane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
funding for the study was terminated
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chester Mays

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Length of Stay (LOS) Return of bowel function Narcotic pain medication requirements Nausea and emesis Pain scores
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral
Keywords
length of stay, nausea, emesis, bowel function, pain scores, narcotic pain medication, post operative period

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXPAREL
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Bilateral, one time injections of 30ml normal saline into the transverse abdominal plane at the time of abdominal component separation.
Intervention Type
Drug
Intervention Name(s)
EXPAREL
Other Intervention Name(s)
bupivacaine liposome injectable suspension
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
length of stay
Description
determine the length of hospital stay after surgery
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
postoperative nausea
Description
evaluate the presence or absence of postoperative nausea
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
postoperative emesis
Description
evaluate for the presence or absence of postoperative emesis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
postoperative return of bowel function
Description
record when bowel function returns following surgery
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
postoperative pain score
Description
assess pain score 0-10 a various time points following surgery
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary Outcome Measure Information:
Title
adjunct narcotic pain medication use
Description
quantify the amount of adjunct narcotic pain medication used following surgery to indirectly assess pain control obtained from the TAP block
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard N Langstein, MD
Organizational Affiliation
University of Rochester Division of Plastic and Reconstructive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12832883
Citation
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Results Reference
background
PubMed Identifier
10697187
Citation
Shestak KC, Edington HJ, Johnson RR. The separation of anatomic components technique for the reconstruction of massive midline abdominal wall defects: anatomy, surgical technique, applications, and limitations revisited. Plast Reconstr Surg. 2000 Feb;105(2):731-8; quiz 739. doi: 10.1097/00006534-200002000-00041.
Results Reference
background
PubMed Identifier
2143588
Citation
Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023.
Results Reference
background
PubMed Identifier
12800903
Citation
Ewart CJ, Lankford AB, Gamboa MG. Successful closure of abdominal wall hernias using the components separation technique. Ann Plast Surg. 2003 Mar;50(3):269-73; discussion 273-4. doi: 10.1097/01.sap.0000046911.07345.0d.
Results Reference
background
PubMed Identifier
18827631
Citation
Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
Results Reference
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PubMed Identifier
12890461
Citation
Kampe S, Warm M, Kasper SM, Diefenbach C. Concept for postoperative analgesia after pedicled TRAM flaps: continuous wound instillation with 0.2% ropivacaine via multilumen catheters. A report of two cases. Br J Plast Surg. 2003 Jul;56(5):478-83. doi: 10.1016/s0007-1226(03)00180-2.
Results Reference
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PubMed Identifier
21701318
Citation
Hivelin M, Wyniecki A, Plaud B, Marty J, Lantieri L. Ultrasound-guided bilateral transversus abdominis plane block for postoperative analgesia after breast reconstruction by DIEP flap. Plast Reconstr Surg. 2011 Jul;128(1):44-55. doi: 10.1097/PRS.0b013e3182174090.
Results Reference
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PubMed Identifier
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Citation
Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
Results Reference
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PubMed Identifier
20175754
Citation
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
result

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Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction

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