Clinical trial NCT03723447: Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
Official title: A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Crohn Disease
Inflammatory Bowel Diseases
Colorectal Cancer
Gastrointestinal Cancer
Gastrointestinal Disease
Digestive System Disease
Pain
Pain, Neuropathic
Intestinal Disease
Keywords: transversus abdominis plane block
tap block
liposomal bupivacaine
exparel
dexamethasone
colorectal surgery
regional anesthesia
bupivacaine
surgery
postoperative pain
pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)
timeFrame: 48-hours
Secondary outcomes:
measure: Post-op Pain Score (Visual Analog Scale)
timeFrame: 72-hours post-surgery
measure: Bowel Motility
timeFrame: 72 hours post-surgery
measure: Postoperative Length of Stay
timeFrame: 30 days post-surgery
measure: Postoperative Complications
timeFrame: 30 days post-surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars Sinai
name: Karen Zaghiyan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mujukian A, Truong A, Tran H, Shane R, Fleshner P, Zaghiyan K. A Standardized Multimodal Analgesia Protocol Reduces Perioperative Opioid Use in Minimally Invasive Colorectal Surgery. J Gastrointest Surg. 2020 Oct;24(10):2286-2294. doi: 10.1007/s11605-019-04385-9. Epub 2019 Sep 12.
citation: Truong A, Mujukian A, Fleshner P, Zaghiyan K. No Pain, More Gain: Reduced Postoperative Opioid Consumption with a Standardized Opioid-Sparing Multimodal Analgesia Protocol in Opioid-Tolerant Patients Undergoing Colorectal Surgery. Am Surg. 2019 Oct 1;85(10):1155-1158.
citation: Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
citation: Truong A, Fleshner PR, Mirocha JM, Tran HP, Shane R, Zaghiyan KN. A Prospective Randomized Trial of Surgeon-Administered Intraoperative Transversus Abdominis Plane Block With Bupivacaine Against Liposomal Bupivacaine: The TINGLE Trial. Dis Colon Rectum. 2021 Jul 1;64(7):888-898. doi: 10.1097/DCR.0000000000002008.