Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®) (TINGLE)
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|ClinicalTrials.gov Identifier: NCT03723447|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : November 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Crohn Disease Inflammatory Bowel Diseases Colorectal Cancer Gastrointestinal Cancer Gastrointestinal Disease Digestive System Disease Pain Pain, Neuropathic Intestinal Disease||Drug: Liposomal bupivacaine Drug: Bupivacaine/epinephrine/dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Bupivacaine/epinephrine/dexamethasone TAP block
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
Other Name: Decadron
Active Comparator: Liposomal bupivacaine TAP block
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Drug: Liposomal bupivacaine
Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
Other Name: Exparel
- Narcotic usage [ Time Frame: 72 hours post-surgery ]All narcotics used during the first 72 hours post-surgery periods will be converted to oral morphine equivalents and totaled
- Post-op Pain [ Time Frame: 72 hours post-surgery ]Visual pain scale recordings will be totaled and averaged during the first 72 hours post-surgery
- Bowel motility [ Time Frame: 72 hours post-surgery ]Time till flatus/ bowel movement
- Hospital length of stay [ Time Frame: 30 days post-surgery ]Time from operation until hospital discharge
- Adverse events [ Time Frame: 30 days post-surgery ]Medical or surgical complications measured by Clavien-Dindo classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723447
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|