NCT03638635

Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Terminated Phase 4 Results posted Last updated 9 September 2019

What this trial tests

Phase 4 trial testing Bupivacaine in Opioid Use in 63 participants. Terminated before completion.

Timeline

14 May 2018

Primary endpoint
16 January 2019

16 January 2019

Quick facts

Lead sponsor	Inova Health Care Services
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	63
Start date	14 May 2018
Primary completion	16 January 2019
Estimated completion	16 January 2019
Sites	6 locations across United States

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →
• Bupivacaine liposome — full drug profile →

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Colectomy — all drugs for Colectomy →
• Colorectal Surgery — all drugs for Colorectal Surgery →

Sponsor

Inova Health Care Services — full company profile →

Who can join

18 and older, any sex, with Opioid Use or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score Secondary · Approximately every 6 hours through postoperative day 3 by 1 pm

Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)

Group	Value	95% CI
Standard Bupivacaine	3	0 – 5
Bupivacaine Liposome	3	0 – 6

Time to Patient Mobilization Secondary · 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

Group	Value	95% CI
Standard Bupivacaine	1	0 – 1
Bupivacaine Liposome	0.5	0 – 1

Time to Return of Bowel Function Secondary · 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

Group	Value	95% CI
Standard Bupivacaine	2	1 – 2
Bupivacaine Liposome	2	1 – 2

Time to Clear Liquid Diet Secondary · 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

Group	Value	95% CI
Standard Bupivacaine	0	0 – 0
Bupivacaine Liposome	0	0 – 1

Time to Low Fiber Diet Secondary · 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

Group	Value	95% CI
Standard Bupivacaine	1.5	1 – 2.25
Bupivacaine Liposome	1	1 – 3

Length of Stay Secondary · Date of surgery to date of discharge (usually up to 4 days after surgery).

Total postoperative hospital stay in days

Group	Value	95% CI
Standard Bupivacaine	3	3 – 5
Bupivacaine Liposome	3.5	3 – 5.75

In-hospital Antiemetic Use Secondary · 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

Group	Value	95% CI
Standard Bupivacaine	2.9	± 3.6
Bupivacaine Liposome	5.6	± 12.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days post-enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Bupivacaine

Serious: 0/39 (0%)

Deaths: 0/39

Bupivacaine Liposome

Serious: 1/24 (4%)

Deaths: 0/24

Serious adverse events (1 terms)

Reaction	System	Standard Bupivacaine	Bupivacaine Liposome
Hospitalization	Surgical and medical procedures	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT03638635 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Coating Materials to Increase the Stability of Liposomes.
   Pasarin D, Ghizdareanu AI, Enascuta CE, Matei CB, et al · · 2023 · cited 84× · PMID 36772080 · DOI 10.3390/polym15030782