Comparing Liposomal Bupivacaine and Regular Bupivacaine for Pain Relief in Laparoscopic Colectomy Surgery Using Bilateral Abdominal Nerve Blocks
Led by Hartford Hospital · Updated on 2025-04-02
114
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Research Team
A
Aseel Walker, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Liposomal bupivacaine plus bupivacaine TAP/RS blocks
Standard bupivacaine TAP/RS blocks
What it is
A combination of liposomal bupivacaine (Exparel) and standard bupivacaine administered as bilateral transversus abdominis plane and rectus sheath blocks before surgery.
Standard bupivacaine (with epinephrine and dexamethasone, as described) given as bilateral transversus abdominis plane and rectus sheath blocks before colectomy.
Role in trial
Test arm evaluating whether the addition of liposomal bupivacaine extends pain relief or reduces opioid need after surgery.
Active comparator arm representing established bupivacaine-based pain control techniques during colectomy.
Primary use
Postoperative pain management in colorectal surgery, aiming for longer pain relief and potentially lower opioid requirements.
Standard pain control following colectomy, with established benefit for perioperative analgesia.
How it is given or performed
Given as a single injection before surgical incision, combining 0.25% bupivacaine and liposomal bupivacaine in defined volumes as part of the TAP and RS regional blocks.
Given as a single local anesthetic mixture (bupivacaine, epinephrine, and dexamethasone) injected for TAP and RS blocks prior to surgery.
Evidence status
Clinical studies show liposomal bupivacaine TAP blocks may reduce postoperative pain and IV opioid use after colorectal surgery, but results are mixed and optimal benefit versus standard bupivacaine is debated.
Standard bupivacaine TAP and RS blocks reliably improve early postoperative pain in colorectal surgery. Multiple RCTs and meta-analyses confirm modest, but consistent, pain score and opioid use reduction versus no block.
Important limitations
Benefit over standard bupivacaine is inconsistent; high cost and off-label status may limit widespread adoption. Most published studies are small, and patient-level responses vary. Registry data show more research is ongoing.
Duration of effect may be limited to the first 24-48 hours after surgery. Opioid reduction beyond early postoperative period is modest. Effects on recovery milestones beyond pain scores are small.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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
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)
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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Published Research Related To This Trial
Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Fourth Edition).
Terese T Horlocker, Erik Vandermeuelen, Sandra L Kopp...
Ultrasound-guided subcostal transversus abdominis plane block with liposomal bupivacaine compared to bupivacaine infiltration for patients undergoing robotic-assisted and laparoscopic hysterectomy: a prospective randomized study.
Effect of ultrasound-guided transversus abdominis plane block with rectus sheath block on patients undergoing laparoscopy-assisted radical resection of rectal cancer: a randomized, double-blind, placebo-controlled trial.
Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery.
Audrey L Stokes, Sanjib D Adhikary, Ashley Quintili...
Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study.
Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment.
Adam C Fields, Scott G Weiner, Luisa J Maldonado...
The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials.
Krishna K Varadhan, Keith R Neal, Cornelius H C Dejong...