RECRUITING

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

Conditions

Bowel Disease Liposomal Bupivacaine Exparel Bupivacaine Laparoscopic Colectomy Transverse Abdominis Plane Blocks (TAP)Regional anesthesia Rectus Sheath Block

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2022-04-27

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05224089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Aseel Walker, MD

CONTACT

860-972-1778

aseel.walker@hhchealth.org

Principal Investigator

Kevin Finkel, MD

PRINCIPAL_INVESTIGATOR

Hartford Hospital

Study Locations (Sites)

Hartford Hospital

Hartford, Connecticut, 06102

United States

Collaborators and Investigators

Sponsor: Hartford Hospital

Kevin Finkel, MD, PRINCIPAL_INVESTIGATOR, Hartford Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-27

Study Completion Date2026-02

Study Record Updates

Study Start Date2022-04-27

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

Liposomal Bupivacaine
Exparel
Bupivacaine
Laparoscopic Colectomy
Transverse Abdominis Plane Blocks (TAP)
Regional anesthesia
Rectus Sheath Block

Additional Relevant MeSH Terms

Bowel Disease