Clinical trial NCT03638635: Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
Official title: TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Opioid Use
Pain, Postoperative
Colectomy
Colorectal Surgery
Keywords: Bupivacaine
Exparel
TAP Block
Opioids
Narcotics
ERAS
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Primary purpose: SUPPORTIVE_CARE

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.

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
* Pregnant
* 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

Primary outcomes:
measure: In-hospital Postoperative Opioid Consumption
timeFrame: up to postoperative day 3 at 1 pm
Secondary outcomes:
measure: Pain Score
timeFrame: Approximately every 6 hours through postoperative day 3 by 1 pm
measure: Time to Patient Mobilization
timeFrame: From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).
measure: Time to Return of Bowel Function
timeFrame: 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).
measure: Time to Clear Liquid Diet
timeFrame: 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).
measure: Time to Low Fiber Diet
timeFrame: 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).
measure: Length of Stay
timeFrame: Date of surgery to date of discharge (usually up to 4 days after surgery).
measure: In-hospital Antiemetic Use
timeFrame: Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
measure: Complications
timeFrame: Within 30 days of surgery
measure: Readmissions
timeFrame: Within 30 days of hospital discharge
measure: Mortality
timeFrame: Within 30 days of surgery
measure: Hospitalization Costs
timeFrame: From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Fairfax Colon & Rectal Surgery, Alexandria Office
state: Virginia
city: Fairfax
country: United States
facility: Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office
state: Virginia
city: Fairfax
country: United States
facility: Fairfax Colon & Rectal Surgery, Fair Oaks Office
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Lansdowne Town Center
country: United States
facility: Fairfax Colon & Rectal Surgery, Loudoun Office
state: Virginia
city: Reston
country: United States
facility: Fairfax Colon & Rectal Surgery, Reston Office
state: Virginia
Study officials:
affiliation: Inova Health Care System
name: Donald Colvin, MD
role: PRINCIPAL_INVESTIGATOR
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