Clinical trial NCT05224089: Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
Official title: Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bowel Disease
Keywords: Liposomal Bupivacaine
Exparel
Bupivacaine
Laparoscopic Colectomy
Transverse Abdominis Plane Blocks (TAP)
Regional anesthesia
Rectus Sheath Block
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, triple blinded, randomized, controlled trial.
Primary purpose: TREATMENT

Brief summary: This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
* English speaking patients
* Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria:

1. Emergency laparoscopic colectomy surgery
2. Patients with distant metastatic cancers (e.g. bone, lung, brain).
3. Scheduled for multi organs resection surgery in addition to colectomy.
4. Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
5. Current colostomies.
6. History of allergy to local anesthetics.
7. Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
8. Weight \< 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
9. Patients who take long acting opioid medication, or on continuous opioid \> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
10. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15
11. Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
12. Refusal or lack of providing the study consent

Primary outcomes:
measure: The highest Numerical Pain Scores
timeFrame: 3 days
Secondary outcomes:
measure: The highest Numerical Pain Scores for the period of 0-47 hours
timeFrame: up to 3 days
measure: All pain scores, mild-moderate-severe.
timeFrame: up to 72 postoperative hours
measure: Postoperative opioid consumption measured in morphine MilliEquivalent (MME)
timeFrame: Up to 6 days post surgery.
measure: Postoperative nausea/vomiting scores
timeFrame: 30 days
measure: Hospital and post-anesthesia care unit length of stay
timeFrame: 6 days
measure: Duration of the study block using the sensory function test
timeFrame: Pre-block intervention, immediately after surgery, up to 3 days
measure: Brief Pain Inventory (Short Form)
timeFrame: On the day of first postoperative visit, the end of the 6th and 12th postoperative months
measure: Block complications
timeFrame: Up to 30 postoperative days
measure: Patient Overall Satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Kevin Finkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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