Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
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| ClinicalTrials.gov Identifier: NCT03638635 |
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Recruitment Status :
Terminated
(Lack of personnel available to complete study.)
First Posted : August 20, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
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Sponsor:
Inova Health Care Services
Information provided by (Responsible Party):
Inova Health Care Services
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opioid Use Pain, Postoperative Colectomy Colorectal Surgery | Drug: Bupivacaine Drug: Bupivacaine liposome | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine. |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention. |
| Primary Purpose: | Supportive Care |
| Official Title: | TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial |
| Actual Study Start Date : | May 14, 2018 |
| Actual Primary Completion Date : | January 16, 2019 |
| Actual Study Completion Date : | January 16, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Drug: Bupivacaine
Abdominal injection of bupivacaine into fascial layer.
Other Name: Marcaine |
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Experimental: 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.
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Drug: Bupivacaine liposome
Abdominal injection of bupivacaine liposome into fascial layer.
Other Name: Exparel |
Primary Outcome Measures :
- In-hospital Postoperative Opioid Consumption [ Time Frame: up to postoperative day 3 at 1 pm ]Daily overall opioid use recorded as morphine equivalents
Secondary Outcome Measures :
- Pain Score [ Time Frame: Approximately every 6 hours through postoperative day 3 by 1 pm ]Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
- Time to 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). ]Number of days from day of surgery until patient mobilization
- Time to 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). ]Number of days from time of surgery until return of bowel function
- Time to 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). ]Number of days from time of surgery until patient tolerates clear liquid diet
- Time to 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). ]Number of days from day of surgery until patient tolerates low fiber diet
- Length of Stay [ Time Frame: Date of surgery to date of discharge (usually up to 4 days after surgery). ]Total postoperative hospital stay in days
- In-hospital Antiemetic Use [ Time Frame: Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery). ]Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
- Complications [ Time Frame: Within 30 days of surgery ]Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
- Readmissions [ Time Frame: Within 30 days of hospital discharge ]Patient readmitted to hospital after discharge
- Mortality [ Time Frame: Within 30 days of surgery ]Patient death after surgery
- Hospitalization Costs [ Time Frame: From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery). ]Total hospitalization costs per patient per this surgical encounter
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638635
Locations
| United States, Virginia | |
| Fairfax Colon & Rectal Surgery, Alexandria Office | |
| Alexandria, Virginia, United States, 22304 | |
| Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office | |
| Fairfax, Virginia, United States, 22031 | |
| Fairfax Colon & Rectal Surgery, Fair Oaks Office | |
| Fairfax, Virginia, United States, 22033 | |
| Inova Fairfax Medical Campus | |
| Falls Church, Virginia, United States, 22042 | |
| Fairfax Colon & Rectal Surgery, Loudoun Office | |
| Lansdowne Town Center, Virginia, United States, 20176 | |
| Fairfax Colon & Rectal Surgery, Reston Office | |
| Reston, Virginia, United States, 20190 | |
Sponsors and Collaborators
Inova Health Care Services
Investigators
| Principal Investigator: | Donald Colvin, MD | Inova Health Care System |
Study Documents (Full-Text)
Documents provided by Inova Health Care Services:
Documents provided by Inova Health Care Services:
Study Protocol and Statistical Analysis Plan [PDF] September 26, 2018
Publications:
| Responsible Party: | Inova Health Care Services |
| ClinicalTrials.gov Identifier: | NCT03638635 |
| Other Study ID Numbers: |
17-2725 |
| First Posted: | August 20, 2018 Key Record Dates |
| Results First Posted: | September 9, 2019 |
| Last Update Posted: | September 9, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Keywords provided by Inova Health Care Services:
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Bupivacaine Exparel TAP Block |
Opioids Narcotics ERAS |
Additional relevant MeSH terms:
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Bupivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |