Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Cancer, Chronic Pain, Irritable Bowel Syndrome (IBS), Post-Surgical Pain, Gastrointestinal, Gastrointestinal, Crohns Disease, Digestive Disease |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 11/18/2018 |
| Start Date: | October 23, 2018 |
| End Date: | September 2019 |
| Contact: | Karen Zaghiyan, MD |
| Email: | kzaghiyan@cshs.org |
| Phone: | 3102899224 |
A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial
Postoperative pain can pose significant challenges in the postoperative recovery of patients
undergoing major colorectal surgery. Traditionally, opioids have played an important role in
treating postoperative pain. It is well established that opioids are highly effective in
relieving pain; however, opioids are associated with numerous side effects that include
nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,
drowsiness, sedation, and allergic reaction. These opioid side effects, which range in
severity, can significantly interfere with discharge home, particularly following colorectal
surgery. Significant interest has grown for the use of guided regional anesthesia,
specifically the use of the transversus abdominis plane (TAP) block to extend the
post-operative analgesic window and ultimately limit opioid use. While bupivacaine
formulations including a steroid has been shown to prolong the anesthetic effects of the
regional field block, a new liposomal-depo formulation of bupivacaine (Exparel) has gained
popularity and has additionally been shown to provide extended analgesia. Although promising
data exists surrounding each modality, liposomal bupivacaine has not been studied in a
well-powered clinical trial specifically in colorectal patients nor compared to a
bupivacaine/steroid mixture.
We are proposing a prospective randomized study of patients undergoing major laparoscopic
colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus
liposomal bupivacaine (Exparel). We hypothesize that the liposomal formulation of bupivacaine
will provide superior perioperative pain control at 48 hours post-operation measured by total
consumed oral morphine equivalents. In addition, we will measure postoperative pain scores,
time until ambulation, antiemetic use, length of postoperative hospital stay, postoperative
ileus, and adverse events directly related or unrelated to TAP block in the 30-day
postoperative period between the three groups.
undergoing major colorectal surgery. Traditionally, opioids have played an important role in
treating postoperative pain. It is well established that opioids are highly effective in
relieving pain; however, opioids are associated with numerous side effects that include
nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,
drowsiness, sedation, and allergic reaction. These opioid side effects, which range in
severity, can significantly interfere with discharge home, particularly following colorectal
surgery. Significant interest has grown for the use of guided regional anesthesia,
specifically the use of the transversus abdominis plane (TAP) block to extend the
post-operative analgesic window and ultimately limit opioid use. While bupivacaine
formulations including a steroid has been shown to prolong the anesthetic effects of the
regional field block, a new liposomal-depo formulation of bupivacaine (Exparel) has gained
popularity and has additionally been shown to provide extended analgesia. Although promising
data exists surrounding each modality, liposomal bupivacaine has not been studied in a
well-powered clinical trial specifically in colorectal patients nor compared to a
bupivacaine/steroid mixture.
We are proposing a prospective randomized study of patients undergoing major laparoscopic
colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus
liposomal bupivacaine (Exparel). We hypothesize that the liposomal formulation of bupivacaine
will provide superior perioperative pain control at 48 hours post-operation measured by total
consumed oral morphine equivalents. In addition, we will measure postoperative pain scores,
time until ambulation, antiemetic use, length of postoperative hospital stay, postoperative
ileus, and adverse events directly related or unrelated to TAP block in the 30-day
postoperative period between the three groups.
Inclusion Criteria:
1. Male or Female
2. Undergoing major laparoscopic colorectal procedure
3. Willingness and ability to sign an informed consent document
4. No allergies to anesthetic or analgesic medications
5. ASA physical status Class I - III
6. Aged 18-90 years
Exclusion Criteria:
1. Refusal to participate in the study
2. Age <18 or > 90 years
3. Pregnancy
4. Contraindications to regional anesthetic including but not limited to:
1. Patient refusal to regional field blockade
2. Allergy
3. Infection at the site of needle insertion
4. Systemic infection
5. Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory
evaluation)
6. Liver or renal disease (SCr > 1.5)
5. Chronic opioid use
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Karen Zaghiyan, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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