Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline for Surgery

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Surgery+1 MoreRopivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline - CombinationProduct
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether a laparoscopic guided TAP block, which is a type of local anesthesia, can help reduce opioid consumption and costs in patients who undergo elective minimally invasive colorectal surgery.

Eligible Conditions
  • Surgery
  • Colorectal Disorders

Treatment Effectiveness

Study Objectives

13 Primary · 9 Secondary · Reporting Duration: 2 months

12 hours
Use of antiemetics in the first 12 hours post op
Visual analog scale pain scores 12 hours post op
2 months
Epidural need
Length of hospital stay
Need for adjunctive systemic nonopioid pain medications
Need to insert nasogastric tube
Outpatient narcotic refill
Post-operative opioid consumption over hospital stay
Prescribed opioid at discharge
Time to first bowel movement
Time to first flatus
24 hours
Use of antiemetics in the first 24 hours post op
Visual analog scale pain scores 24 hours post op
36 hours
Use of antiemetics in the first 36 hours post op
Visual analog scale pain scores 36 hours post op
48 hours
Use of antiemetics in the first 48 hours post op
Visual analog scale pain scores 48 hours post op
72 hours
Need for postoperative patient-controlled analgesia (PCA)
Post-operative opioid consumption in the first 72 hours
Antiemetics
Visual analog scale pain scores 72 hours post op
Visual analog scale pain scores in the PACU

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Liposomal Bupivacaine (Exparel)
1 of 2
Investigational Arm
1 of 2

Active Control

Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline · No Placebo Group · Phase 2

Investigational Arm
CombinationProduct
Experimental Group · 1 Intervention: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline · Intervention Types: CombinationProduct
Liposomal Bupivacaine (Exparel)
Drug
ActiveComparator Group · 1 Intervention: Liposomal bupivacaine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,590 Previous Clinical Trials
1,927,128 Total Patients Enrolled
3 Trials studying Surgery
260 Patients Enrolled for Surgery
Brandon C ChapmanPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age 18 - 100 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with all study procedures and be available for the duration of the study.
Laparoscopic, robotic, or a hybrid colorectal resection with or without an ostomy is a safe and effective procedure for the treatment of benign or malignant colorectal disease.