Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

Phase 4RecruitingNCT05224089

Hartford Hospital114 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

114

Conditions

Bowel Disease

Interventions

Liposomal Bupivicaine/Bupivacaine AdmixtureDRUG

60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL

Bupivacaine HCLDRUG

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hartford Hospital

Hartford, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

The highest Numerical Pain Scores

To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.

Time frame: 3 days

Secondary Outcomes

The highest Numerical Pain Scores for the period of 0-47 hours

To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery by patients in the two groups, using the Brief Pain Inventory (Short Form), this measurement will be done at the 26th and 50th postoperative hour with a range on +3/-2 hours.

Time frame: up to 3 days

All pain scores, mild-moderate-severe.

Proportion of patients experiencing moderate or severe pain, the scores will be grouped such that 1-3 is considered mild pain, 4-6 moderate pain, and 7-10 severe pain.

Time frame: up to 72 postoperative hours

Postoperative opioid consumption measured in morphine MilliEquivalent (MME)

Postoperative total opioid consumption measured in morphine MilliEquivalent (MME) will be collected starting from the time in post-anaesthesia care unit up to the first 6 postoperative days. Patients will continue to report their opioid consumption after discharge days using the pain and medication diary up to 6 days post-surgery.

Time frame: Up to 6 days post surgery.

Postoperative nausea/vomiting scores

Using a validated measure; the Simplified (Post-operative nausea and vomiting Impact Scale 17 which consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This form will be completed either by the assigned nurse or the study coordinator immediately after surgery in the post-anesthesia care unit, postoperative day#1, postoperative day#2, postoperative day#3, and during the first follow up visit.

Central Contacts

Aseel Walker, MD

CONTACT

860-972-1778 aseel.walker@hhchealth.org

Data from ClinicalTrials.gov

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