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Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction

Abdominal Wall Reconstruction: Postoperative Outcomes Using Transverse Abdominal Plane Anesthesia

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02274077
Enrollment
0
Registered
2014-10-24
Start date
2016-01-31
Completion date
2017-06-30
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral

Keywords

length of stay, nausea, emesis, bowel function, pain scores, narcotic pain medication, post operative period

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

Interventions

DRUGEXPAREL
DRUGNormal Saline

Sponsors

Chester Mays
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
length of stayparticipants will be followed for the duration of hospital stay, an expected average of 1 weekdetermine the length of hospital stay after surgery
postoperative nauseaparticipants will be followed for the duration of hospital stay, an expected average of 1 weekevaluate the presence or absence of postoperative nausea
postoperative emesisparticipants will be followed for the duration of hospital stay, an expected average of 1 weekevaluate for the presence or absence of postoperative emesis
postoperative return of bowel functionparticipants will be followed for the duration of hospital stay, an expected average of 1 weekrecord when bowel function returns following surgery
postoperative pain scoreparticipants will be followed for the duration of hospital stay, an expected average of 1 weekassess pain score 0-10 a various time points following surgery

Secondary

MeasureTime frameDescription
adjunct narcotic pain medication useparticipants will be followed for the duration of hospital stay, an expected average of 1 weekquantify the amount of adjunct narcotic pain medication used following surgery to indirectly assess pain control obtained from the TAP block

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026