Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | June 2017 |
| Contact: | Chester J Mays, MD |
| Email: | chester_mays@urmc.rochester.edu |
| Phone: | 585-275-1000 |
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
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
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.
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.
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.
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