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New treatment option for Bowel Disease
Official title Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
ClinicalTrials.gov ID: NCT05224089
What this study is testing
What is Liposomal Bupivicaine/Bupivacaine Admixture?
Liposomal Bupivicaine/Bupivacaine Admixture is an investigational medicine, being studied as a potential treatment for bowel disease.
Also referred to as Bupivacaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Current colostomies.
- History of allergy to local anesthetics.
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
- Refusal or lack of providing the study consent
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.