Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Phase 4

Terminated

• Conditions: Pain, Postoperative; Colectomy; Colorectal Surgery; Opioid Use
• Interventions: Drug: Bupivacaine; Drug: Bupivacaine liposome

• Registration Number: NCT03638635
• Lead Sponsor: Inova Health Care Services

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.

Study Timeline

• Study First Submitted: 2017-08-21
• Study Start: 2018-05-14
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Status Verified: 2019-04
• Results First Submitted: 2019-04-22
• Results First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Bupivacaine	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.
Bupivacaine Liposome	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.

Primary Outcome Measures

Name	Time	Method
In-hospital Postoperative Opioid Consumption	up to postoperative day 3 at 1 pm	Daily overall opioid use recorded as morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Pain Score	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	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	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	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	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	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 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	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	Within 30 days of hospital discharge	Patient readmitted to hospital after discharge
Mortality	Within 30 days of surgery	Patient death after surgery
Hospitalization Costs	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

Trial Locations

Locations (6)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States

Fairfax Colon & Rectal Surgery, Fair Oaks Office; 🇺🇸 Fairfax, Virginia, United States

Fairfax Colon & Rectal Surgery, Loudoun Office; 🇺🇸 Lansdowne Town Center, Virginia, United States

Fairfax Colon & Rectal Surgery, Reston Office; 🇺🇸 Reston, Virginia, United States

Fairfax Colon & Rectal Surgery, Alexandria Office; 🇺🇸 Alexandria, Virginia, United States

Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office; 🇺🇸 Fairfax, Virginia, United States