Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Hartford Hospital
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- The highest Numerical Pain Scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Emergency laparoscopic colectomy surgery
- •Patients with distant metastatic cancers (e.g. bone, lung, brain).
- •Scheduled for multi organs resection surgery in addition to colectomy.
- •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.
- •Current colostomies.
- •History of allergy to local anesthetics.
- •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
- •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.
- •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.
- •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
- •Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
- •Refusal or lack of providing the study consent
Arms & Interventions
Liposomal Bupivacaine/Bupivacaine HCL
20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Intervention: Liposomal Bupivicaine/Bupivacaine Admixture (Drug)
Liposomal Bupivacaine/Bupivacaine HCL
20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Intervention: Bupivacaine HCL (Drug)
Regular Bupivacaine Arm
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Intervention: Bupivacaine HCL (Drug)
Outcomes
Primary Outcomes
The highest Numerical Pain Scores
Time Frame: 3 days
To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.
Secondary Outcomes
- The highest Numerical Pain Scores for the period of 0-47 hours(up to 3 days)
- All pain scores, mild-moderate-severe.(up to 72 postoperative hours)
- Postoperative opioid consumption measured in morphine MilliEquivalent (MME)(Up to 6 days post surgery.)
- Block complications(Up to 30 postoperative days)
- Postoperative nausea/vomiting scores(30 days)
- Hospital and post-anesthesia care unit length of stay(6 days)
- Duration of the study block using the sensory function test(Pre-block intervention, immediately after surgery, up to 3 days)
- Patient Overall Satisfaction(30 days)
- Brief Pain Inventory (Short Form)(On the day of first postoperative visit, the end of the 6th and 12th postoperative months)
Investigators
Kevin Finkel
Director of Clinical Research - HH Department of Anesthesiology
Hartford Hospital