TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine
- Conditions
- Opioid Use
- Sponsor
- Inova Health Care Services
- Enrollment
- 63
- Locations
- 6
- Primary Endpoint
- In-hospital Postoperative Opioid Consumption
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.
Detailed Description
Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects. Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively). In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery
Exclusion Criteria
- •Allergic to local anesthetics
- •Unable to provide consent
- •On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
- •Undergoing emergent operations
- •Undergoing loop ileostomy reversal
- •Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs
Arms & Interventions
Standard Bupivacaine
Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Intervention: Bupivacaine
Bupivacaine Liposome
Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.
Intervention: Bupivacaine liposome
Outcomes
Primary Outcomes
In-hospital Postoperative Opioid Consumption
Time Frame: up to postoperative day 3 at 1 pm
Daily overall opioid use recorded as morphine equivalents
Secondary Outcomes
- Pain Score(Approximately every 6 hours through postoperative day 3 by 1 pm)
- Time to Patient Mobilization(From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Return of Bowel Function(From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Clear Liquid Diet(From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).)
- Time to Low Fiber Diet(From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).)
- Length of Stay(Date of surgery to date of discharge (usually up to 4 days after surgery).)
- In-hospital Antiemetic Use(Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).)
- Complications(Within 30 days of surgery)
- Readmissions(Within 30 days of hospital discharge)
- Mortality(Within 30 days of surgery)
- Hospitalization Costs(From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).)