Colorectal DisordersPhase 2TAPNCT05216055
Transverse Abdominus Plane Block Study
A Phase 2 study testing Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline and Liposomal bupivacaine in people with Colorectal Disorders and Surgery, run by University of Colorado, Denver.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Disorders, Surgery
- What is being tested?
- Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline and Liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2022to 27 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provision to sign and date the consent form.
- stated willingness to comply with all study procedures and be available for the duration of the study.
- Male and female patients aged 18 and older
- Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy
Who cannot join
- Pregnant or breastfeeding patients
- Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
- Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
- Incarcerated individuals
- Age less than 18 years-old
- Urgent/emergent operations as defined by need for operation within 24 hours
- Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
- Enrollment in another concurrent study with use of investigational drugs
About this study
Official title: Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- Colorectal Disorders, Surgery
- Being tested
- Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline, Liposomal bupivacaine
- Keywords
- Benign, Malignant, Laparoscopic Surgery, Robotic Surgery, Hybrid Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal salineCombination 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
Liposomal bupivacaineDrug
Also called Exparel
Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL
| Study group | Role | What they receive |
|---|---|---|
| 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.
1. Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg)
2. Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug)
3. Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg)
4. Normal saline 0.9%, 18.5mL Receives: Combination Product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline |
| 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:
1. Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg)
2. Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms). Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Post-operative opioid consumption over hospital stay
Total morphine dose equivalents administered throughout hospital stay
Measured: 2 months
Visual analog scale pain scores in the PACU
Visual analog scale (VAS) pain scores in the PACU
Measured: 72 hours
Visual analog scale pain scores 12 hours post op
Visual analog scale pain scores 12 hours post op
Measured: 12 hours
Visual analog scale pain scores 24 hours post op
Visual analog scale pain scores 24 hours post op
Measured: 24 hours
Visual analog scale pain scores 36 hours post op
Visual analog scale pain scores 36 hours post op
Measured: 36 hours
Visual analog scale pain scores 48 hours post op
Visual analog scale pain scores 48 hours post op
Measured: 48 hours
Visual analog scale pain scores 72 hours post op
Visual analog scale pain scores 72 hours post op
Measured: 72 hours
Epidural need
Need for an epidural post-operatively. Reviewed using the EMR.
Measured: 2 months
Need for postoperative patient-controlled analgesia (PCA)
Determined by review of EMR. Patients use or non-use of PCA.
Measured: 72 hours
Need for adjunctive systemic nonopioid pain medications
Adjunctive systemic nonopioid pain medications
Measured: 2 months
Prescribed opioid at discharge
Amount of opioid prescribed at discharge
Measured: 2 months
Outpatient narcotic refill
Use the EMR to determine outpatient narcotic refill
Measured: 2 months
Secondary outcomes (9)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours
Time to first flatus
Days from surgery to first flatus postoperatively. Reviewed using the EMR.
Measured: 2 months
Time to first bowel movement
Days from surgery to first bowel movement postoperatively. Reviewed using the EMR.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start19 Apr 2022
- Primary completion16 Dec 2022
- Study completion27 Dec 2022
Why it stopped: No Accrual. PI left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brandon C Chapman, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216055
- Sponsor's protocol ID
- 20-2574.cc
- Acronym
- TAP
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05216055
- Acronym / sponsor ID
- TAP / 20-2574.cc
- Conditions
- Colorectal Disorders, Surgery
- Keywords
- Benign, Malignant, Laparoscopic Surgery, Robotic Surgery, Hybrid Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Accrual. PI left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Combination Product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal salineThe 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. 1. Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) 2. Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) 3. Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) 4. Normal saline 0.9%, 18.5mL |
| Liposomal Bupivacaine (Exparel) | Active comparator | Drug: Liposomal bupivacaineThe study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows: 1. Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) 2. Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- provision to sign and date the consent form.
- stated willingness to comply with all study procedures and be available for the duration of the study.
- Male and female patients aged 18 and older
- Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding patients
- Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
- Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
- Incarcerated individuals
- Age less than 18 years-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal salineRopivacaine 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 | Combination product | Investigational Arm |
| Liposomal bupivacaineAlso: ExparelLiposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL | Drug | Liposomal Bupivacaine (Exparel) |
Primary outcome
Post-operative opioid consumption in the first 72 hours
Time frame: 72 hours
Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents.
Post-operative opioid consumption over hospital stay
Time frame: 2 months
Total morphine dose equivalents administered throughout hospital stay
Visual analog scale pain scores in the PACU
Time frame: 72 hours
Visual analog scale (VAS) pain scores in the PACU
Visual analog scale pain scores 12 hours post op
Time frame: 12 hours
Visual analog scale pain scores 12 hours post op
Visual analog scale pain scores 24 hours post op
Time frame: 24 hours
Visual analog scale pain scores 24 hours post op
Visual analog scale pain scores 36 hours post op
Time frame: 36 hours
Visual analog scale pain scores 36 hours post op
Visual analog scale pain scores 48 hours post op
Time frame: 48 hours
Visual analog scale pain scores 48 hours post op
Visual analog scale pain scores 72 hours post op
Time frame: 72 hours
Visual analog scale pain scores 72 hours post op
Epidural need
Time frame: 2 months
Need for an epidural post-operatively. Reviewed using the EMR.
Need for postoperative patient-controlled analgesia (PCA)
Time frame: 72 hours
Determined by review of EMR. Patients use or non-use of PCA.
Need for adjunctive systemic nonopioid pain medications
Time frame: 2 months
Adjunctive systemic nonopioid pain medications
Prescribed opioid at discharge
Time frame: 2 months
Amount of opioid prescribed at discharge
Outpatient narcotic refill
Time frame: 2 months
Use the EMR to determine outpatient narcotic refill
9 secondary outcomes
Length of hospital stay
Time frame: 2 months
Use of antiemetics in the first 12 hours post op
Time frame: 12 hours
Use of antiemetics in the first 24 hours post op
Time frame: 24 hours
Use of antiemetics in the first 36 hours post op
Time frame: 36 hours
Use of antiemetics in the first 48 hours post op
Time frame: 48 hours
Use of antiemetics in the first 72 hours post op
Time frame: 72 hours
Time to first flatus
Time frame: 2 months
Time to first bowel movement
Time frame: 2 months
Need to insert nasogastric tube
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon C Chapman principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline and Liposomal bupivacaine in people with Colorectal Disorders and Surgery, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative opioid consumption in the first 72 hours (time frame: 72 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.