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Completed

NCT Number: NCT03723447

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Undergoing major laparoscopic colorectal procedure
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or analgesic medications
  • ASA physical status Class I - III
  • Aged 18-90 years

Exclusion criteria

  • Refusal to participate in the study
  • Age <18 or > 90 years
  • Pregnancy
  • Contraindications to regional anesthetic including but not limited to:
  • Patient refusal to regional field blockade
  • Allergy
  • Infection at the site of needle insertion
  • Systemic infection
  • Bleeding diathesis or coagulopathy (as diagnosed by history or laboratory evaluation)
  • Liver or renal disease (SCr > 1.5)
  • Chronic opioid use

Treatment and study plan

Liposomal bupivacaine

Drug

Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.

Other names: Exparel

Bupivacaine/epinephrine/dexamethasone

Drug

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

Other names: Decadron

Primary outcomes

  1. Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)

    Time frame: 48-hours

Secondary outcomes

  1. Post-op Pain Score (Visual Analog Scale)

    Time frame: 72-hours post-surgery

    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.

  2. Bowel Motility

    Time frame: 72 hours post-surgery

    Time till first bowel movement

  3. Postoperative Length of Stay

    Time frame: 30 days post-surgery

    Time from operation until hospital discharge

  4. Postoperative Complications

    Time frame: 30 days post-surgery

    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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: TINGLE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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