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Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Primary Purpose

Opioid Use, Pain, Postoperative, Colectomy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Bupivacaine liposome
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use focused on measuring Bupivacaine, Exparel, TAP Block, Opioids, Narcotics, ERAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fairfax Colon & Rectal Surgery, Alexandria Office
  • Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office
  • Fairfax Colon & Rectal Surgery, Fair Oaks Office
  • Inova Fairfax Medical Campus
  • Fairfax Colon & Rectal Surgery, Loudoun Office
  • Fairfax Colon & Rectal Surgery, Reston Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Bupivacaine

Bupivacaine Liposome

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

In-hospital Postoperative Opioid Consumption
Daily overall opioid use recorded as morphine equivalents

Secondary Outcome Measures

Pain Score
Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
Time to Patient Mobilization
Number of days from day of surgery until patient mobilization
Time to Return of Bowel Function
Number of days from time of surgery until return of bowel function
Time to Clear Liquid Diet
Number of days from time of surgery until patient tolerates clear liquid diet
Time to Low Fiber Diet
Number of days from day of surgery until patient tolerates low fiber diet
Length of Stay
Total postoperative hospital stay in days
In-hospital Antiemetic Use
Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
Complications
Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
Readmissions
Patient readmitted to hospital after discharge
Mortality
Patient death after surgery
Hospitalization Costs
Total hospitalization costs per patient per this surgical encounter

Full Information

First Posted
August 21, 2017
Last Updated
August 14, 2019
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT03638635
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of personnel available to complete study.
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative, Colectomy, Colorectal Surgery
Keywords
Bupivacaine, Exparel, TAP Block, Opioids, Narcotics, ERAS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking
ParticipantOutcomes Assessor
Masking Description
The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bupivacaine Liposome
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Abdominal injection of bupivacaine into fascial layer.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Other Intervention Name(s)
Exparel
Intervention Description
Abdominal injection of bupivacaine liposome into fascial layer.
Primary Outcome Measure Information:
Title
In-hospital Postoperative Opioid Consumption
Description
Daily overall opioid use recorded as morphine equivalents
Time Frame
up to postoperative day 3 at 1 pm
Secondary Outcome Measure Information:
Title
Pain Score
Description
Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
Time Frame
Approximately every 6 hours through postoperative day 3 by 1 pm
Title
Time to Patient Mobilization
Description
Number of days from day of surgery until patient mobilization
Time Frame
From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).
Title
Time to Return of Bowel Function
Description
Number of days from time of surgery until return of bowel function
Time Frame
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).
Title
Time to Clear Liquid Diet
Description
Number of days from time of surgery until patient tolerates clear liquid diet
Time Frame
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).
Title
Time to Low Fiber Diet
Description
Number of days from day of surgery until patient tolerates low fiber diet
Time Frame
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).
Title
Length of Stay
Description
Total postoperative hospital stay in days
Time Frame
Date of surgery to date of discharge (usually up to 4 days after surgery).
Title
In-hospital Antiemetic Use
Description
Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
Time Frame
Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
Title
Complications
Description
Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
Time Frame
Within 30 days of surgery
Title
Readmissions
Description
Patient readmitted to hospital after discharge
Time Frame
Within 30 days of hospital discharge
Title
Mortality
Description
Patient death after surgery
Time Frame
Within 30 days of surgery
Title
Hospitalization Costs
Description
Total hospitalization costs per patient per this surgical encounter
Time Frame
From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Colvin, MD
Organizational Affiliation
Inova Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairfax Colon & Rectal Surgery, Alexandria Office
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fairfax Colon & Rectal Surgery, Fair Oaks Office
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Fairfax Colon & Rectal Surgery, Loudoun Office
City
Lansdowne Town Center
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Fairfax Colon & Rectal Surgery, Reston Office
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11576144
Citation
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Results Reference
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PubMed Identifier
22312327
Citation
Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.
Results Reference
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PubMed Identifier
27943522
Citation
Rashid A, Gorissen KJ, Ris F, Gosselink MP, Shorthouse JR, Smith AD, Pandit JJ, Lindsey I, Crabtree NA. No benefit of ultrasound-guided transversus abdominis plane blocks over wound infiltration with local anaesthetic in elective laparoscopic colonic surgery: results of a double-blind randomized controlled trial. Colorectal Dis. 2017 Jul;19(7):681-689. doi: 10.1111/codi.13578.
Results Reference
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PubMed Identifier
27129571
Citation
Oh TK, Yim J, Kim J, Eom W, Lee SA, Park SC, Oh JH, Park JW, Park B, Kim DH. Effects of preoperative ultrasound-guided transversus abdominis plane block on pain after laparoscopic surgery for colorectal cancer: a double-blind randomized controlled trial. Surg Endosc. 2017 Jan;31(1):127-134. doi: 10.1007/s00464-016-4941-7. Epub 2016 Apr 29.
Results Reference
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PubMed Identifier
23389068
Citation
Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
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PubMed Identifier
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Citation
Favuzza J, Delaney CP. Outcomes of discharge after elective laparoscopic colorectal surgery with transversus abdominis plane blocks and enhanced recovery pathway. J Am Coll Surg. 2013 Sep;217(3):503-6. doi: 10.1016/j.jamcollsurg.2013.03.030. Epub 2013 Jun 28.
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PubMed Identifier
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Citation
Ris F, Findlay JM, Hompes R, Rashid A, Warwick J, Cunningham C, Jones O, Crabtree N, Lindsey I. Addition of transversus abdominis plane block to patient controlled analgesia for laparoscopic high anterior resection improves analgesia, reduces opioid requirement and expedites recovery of bowel function. Ann R Coll Surg Engl. 2014 Nov;96(8):579-85. doi: 10.1308/003588414X13946184900921.
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Barron KI, Lamvu GM, Schmidt RC, Fisk M, Blanton E, Patanwala I. Wound Infiltration With Extended-Release Versus Short-Acting Bupivacaine Before Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2017 Feb;24(2):286-292. doi: 10.1016/j.jmig.2016.11.002. Epub 2016 Nov 14.
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Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

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