Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)

Pain Clinical Trial

— TINGLE  

Official title:

A Prospective Randomized Trial of Transversus Abdominis Plane (TAP) INtraoperative Block With Bupivacaine/Dexamethasone aGainst Liposomal Bupivacaine (Exparel®): the TINGLE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723447
• Other study ID #: Pro00053363
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: February 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Crohn Disease
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Cancer
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Inflammatory Bowel Diseases
• Intestinal Disease
• Intestinal Diseases
• Neuralgia
• Pain
• Pain, Neuropathic
• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine
Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
• Bupivacaine/epinephrine/dexamethasone
Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)		48-hours
Secondary	Post-op Pain Score (Visual Analog Scale)	Visual pain scale recordings will be totaled and averaged during the first 72-hours post-surgery. Visual analog scale is determined by nursing staff when assessing pain scores. Scores range from 0-10 with 10 being the most pain. These values are typically interpreted by nursing staff as mild, moderate, or severe pain and pain medication is given accordingly.	72-hours post-surgery
Secondary	Bowel Motility	Time till first bowel movement	72 hours post-surgery
Secondary	Postoperative Length of Stay	Time from operation until hospital discharge	30 days post-surgery
Secondary	Postoperative Complications	Medical or surgical complications measured by Clavien-Dindo classification; Clavien-Dindo grade I: any deviation from normal postoperative course; no pharmacological or surgical treatment, endoscopic, or radiological interventions were required. Acceptable therapeutic regiments are drugs such as anti-emetics, antipyretics, analgesics, diuretics, and electrolytes. Wound infections or small abscess requiring incision at bedside is within this category; Clavien-Dindo grade II: Normal course altered; Pharacological management other than in grade 1. Blood transfusions and total parenteral nutrition are also included.; Clavien-Dindo grade III: complications that require intervention of various degrees; management of these complications require an intervention under local anesthesia or general or epidural anesthesia; Clavien-Dindo grade IV: complications threatening the life of a patient; manifesting in organ dysfunction, including dialysis	30 days post-surgery