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

ConditionBowel Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHartford Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal Bupivicaine/Bupivacaine Admixture

    Drug

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

  • Bupivacaine HCL

    Drug

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

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Liposomal Bupivacaine/Bupivacaine HCLExperimental treatment 2 interventions
Group B: Regular Bupivacaine ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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.
4

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.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.