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No Accrual. PI left Institution
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Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.
This is a non-inferiority single-blinded randomized trial aiming to study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Arm | Experimental | The study drug volume, concentration, and dose of treatment arm #1 selected is based on the Principal Investigator's prior experience recommendations by the Food Drug Administration (FDA), and evidence based on prior literature. The final concentration of ropivacaine is 0.375% and final volume of the mixture is 60mL.
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| Liposomal Bupivacaine (Exparel) | Active Comparator | The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline | Combination Product | Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) Normal saline 0.9%, 18.5mL |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative opioid consumption in the first 72 hours | Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents. | 72 hours |
| Post-operative opioid consumption over hospital stay | Total morphine dose equivalents administered throughout hospital stay | 2 months |
| Visual analog scale pain scores in the PACU | Visual analog scale (VAS) pain scores in the PACU | 72 hours |
| Visual analog scale pain scores 12 hours post op | Visual analog scale pain scores 12 hours post op | 12 hours |
| Visual analog scale pain scores 24 hours post op | Visual analog scale pain scores 24 hours post op | 24 hours |
| Visual analog scale pain scores 36 hours post op | Visual analog scale pain scores 36 hours post op | 36 hours |
| Visual analog scale pain scores 48 hours post op | Visual analog scale pain scores 48 hours post op | 48 hours |
| Visual analog scale pain scores 72 hours post op | Visual analog scale pain scores 72 hours post op |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on length of hospital stay following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Calculating the length of hospital stay will allow for evaluation of effectiveness of dual adjunct therapy in context of ERAS protocol compared to liposomal bupivacaine | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon C Chapman | University of Colorado, Denver | Principal Investigator |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020927 | Dexmedetomidine |
| C004180 | dexamethasone 21-phosphate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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This study is a randomized single blinded trial to minimize bias and provide highest level of evidence in use as part of effort to reduce opioid use consumption. This study cannot be performed as a double blinded RCT due to Exparel being milky white color in appearance and cannot be altered or shielded from being visible by the operating surgeon performing the TAP block.
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| Liposomal bupivacaine | Drug | Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL |
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| 72 hours |
| Epidural need | Need for an epidural post-operatively. Reviewed using the EMR. | 2 months |
| Need for postoperative patient-controlled analgesia (PCA) | Determined by review of EMR. Patients use or non-use of PCA. | 72 hours |
| Need for adjunctive systemic nonopioid pain medications | Adjunctive systemic nonopioid pain medications | 2 months |
| Prescribed opioid at discharge | Amount of opioid prescribed at discharge | 2 months |
| Outpatient narcotic refill | Use the EMR to determine outpatient narcotic refill | 2 months |
| Use of antiemetics in the first 12 hours post op | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR. | 12 hours |
| Use of antiemetics in the first 24 hours post op | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR. | 24 hours |
| Use of antiemetics in the first 36 hours post op | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR. | 36 hours |
| Use of antiemetics in the first 48 hours post op | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR. | 48 hours |
| Use of antiemetics in the first 72 hours post op | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR. | 72 hours |
| Time to first flatus | Days from surgery to first flatus postoperatively. Reviewed using the EMR. | 2 months |
| Time to first bowel movement | Days from surgery to first bowel movement postoperatively. Reviewed using the EMR. | 2 months |
| Need to insert nasogastric tube | To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Reviewed using the EMR. | 2 months |
| D000588 |
| Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |