Colorectal DisordersPhase 4ExparelNCT04005859
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
A Phase 4 study testing Exparel and IV Lidocaine in people with Colorectal Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Exparel and IV Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2018to 20 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Elective laparoscopic colorectal surgery
- ASA I-III
Who cannot join
- Contraindication to Na Channel Blocker
- Chronic Opioid use
- Liver dysfunction
- Renal insufficiency
- Epilepsy
- Psychomotor retardation
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- BMI >40
- Sleep Apnea
- Cardiac Rhythm Disorders
- Planned open or concomitant procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.
- Conditions
- Colorectal Disorders
- Being tested
- Exparel, IV Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
- Liposomal bupivacaine TAP block (experimental arm)
- Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
- A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
- The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
- Adhesive tapes will be applied at the level of the TAP block puncture sites.
IV LidocaineDrug
- Intravenous Lidocaine infusion (control arm, current standard of care)
- 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
- 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
- Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL: IV Lido | Active comparator | CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) Receives: Drug: IV Lidocaine |
| EXPERIMENTAL: Exparel | Experimental | EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel) Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Pain Scale (VRS) - 4 Week Post-op
Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
Measured: Single VRS assessed at 4-week post-op visit (or phone call)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start22 Feb 2018
- Primary completion9 May 2019
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Kasten, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005859
- Sponsor's protocol ID
- 01-18-16
- Acronym
- Exparel
- Status last verified
- Oct 2021
- First submitted
- 27 Jun 2019
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
- ClinicalTrials.gov ID
- NCT04005859
- Acronym / sponsor ID
- Exparel / 01-18-16
- Conditions
- Colorectal Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL: IV Lido | Active comparator | Drug: IV LidocaineCONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido) |
| EXPERIMENTAL: Exparel | Experimental | Drug: ExparelEXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Elective laparoscopic colorectal surgery
- ASA I-III
Key exclusion criteria (10 listed)
- Contraindication to Na Channel Blocker
- Chronic Opioid use
- Liver dysfunction
- Renal insufficiency
- Epilepsy
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 |
|---|---|---|
| Exparel2. Liposomal bupivacaine TAP block (experimental arm) 1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service. 2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks. 3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations. 4. Adhesive tapes will be applied at the level of the TAP block puncture sites. | Drug | EXPERIMENTAL: Exparel |
| IV Lidocaine1. Intravenous Lidocaine infusion (control arm, current standard of care) 1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip. 3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites. | Drug | CONTROL: IV Lido |
Primary outcome
Verbal Pain Scale (VRS) - 4 Week Post-op
Time frame: Single VRS assessed at 4-week post-op visit (or phone call)
Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kevin Kasten, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel and IV Lidocaine in people with Colorectal Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Verbal Pain Scale (VRS) - 4 Week Post-op (time frame: Single VRS assessed at 4-week post-op visit (or phone call)). 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 9 Aug 2022.