The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery.
Alexander J Kim, Robert Jason Yong, Richard D Urman
https://pubmed.ncbi.nlm.nih.gov/28742435Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05224089
Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures
Led by Hartford Hospital · Updated on 2025-04-02
114
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of liposomal bupivacaine (Exparel) compared to regular bupivacaine with adjunct drugs in pain control for patients undergoing laparoscopic colectomy, a surgery involving the colon. This is a prospective, triple-blinded, randomized controlled study conducted at a single center to compare the effectiveness of these pain management techniques in this surgical setting. Participants will receive either a mixture of liposomal bupivacaine combined with standard bupivacaine or regular bupivacaine with epinephrine, dexamethasone, and saline. Both treatments involve bilateral mid-abdominal transverse abdominis plane (TAP) blocks and rectus sheath (RS) blocks, with precise dosing and syringe division for administration on each side. The study monitors these two drug regimens during the surgical and postoperative periods. During the study, participants will be monitored for pain levels using numerical pain scores over three days, opioid use, nausea, vomiting, hospital stay length, sensory block duration, and patient satisfaction. Assessments include sensory tests immediately after surgery and follow-up pain inventories up to 12 months. Safety and any block-related complications will also be tracked for up to 30 days post-surgery. The total participation period includes immediate postoperative monitoring and extended follow-up for pain and satisfaction.
CONDITIONS
Brief Title
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective laparoscopic colectomy surgery by one of the 4 colorectal surgeons in the study
- English speaking patients
- Patients with American Society of Anesthesiology (ASA) physical status score I to IV
- Adults aged 18 years or older
You will not qualify if you...
- Emergency laparoscopic colectomy surgery
- Patients with distant metastatic cancers such as bone, lung, or brain cancer
- Scheduled for multi-organ resection surgery besides colectomy
- Contraindications to TAP or RS blocks, including anatomical abnormalities, prior surgeries limiting block placement, or infection at injection site
- Current colostomies
- History of allergy to local anesthetics
- Coagulopathy or coagulation disorders, or receiving antithrombotic medications contraindicating nerve block
- Weight less than 40 kg due to dosage safety concerns
- Use of long-acting opioids or continuous opioid over 50 MME daily for at least 30 days within 90 days before surgery
- Chronic pain syndrome with recent consultation to chronic pain service
- Current or recent substance abuse within 3 months, including illicit drugs or excessive alcohol use
- Pregnant, nursing, or planning pregnancy during study or within 1 month postoperatively
- Refusal or lack of consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 days post surgery
Participants receive bilateral mid-abdominal transverse abdominis plane and rectus sheath blocks with either liposomal bupivacaine/bupivacaine admixture or regular bupivacaine during laparoscopic colectomy surgery.
1 visit for block administration and surgery plus daily assessments for up to 6 days
Follow-up
Duration - Up to 30 days post surgery
Participants are monitored for pain scores, opioid consumption, nausea/vomiting, complications, and overall satisfaction after surgery.
Several visits including postoperative days 1 to 3, and follow-up assessments at 30 days
Long-term Monitoring
Duration - Up to 12 months post surgery
Participants complete brief pain inventory assessments to evaluate pain and recovery at 1, 6, and 12 months after surgery.
3 visits (at 1, 6, and 12 months postoperative)
Trial Site Locations
Total: 1 location
1
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
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Research Team
A
Aseel Walker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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