Opioid UsePhase 4NCT03730402
Laparoscopic Assisted Plane Block (LAPB) Trial
A Phase 4 study testing Bupivacaine, Exparel 266 milligram Per 20 ML Injection and Saline in people with Opioid Use, run by Santa Barbara Cottage Hospital at 1 site in United States.
Trial summary
This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- Bupivacaine, Exparel 266 milligram Per 20 ML Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 14 Apr 2021
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old
- Patients undergoing non-emergent laparoscopic surgery with planned or continued admission for at least 1 night
- Patients who receive fully laparoscopic procedures including ports up to 15mm, and any blunt dilation of port fascia or sharp extension of skin incisions for specimen extraction.
Who cannot join
- Patients under 18 or over 80 years old
- Patients who are pregnant
- Patients who are unable to consent themselves
- Patients who undergo an appendectomy for acute appendicitis
- Patients who undergo emergent surgery
- Patients who are converted to open procedure
Show all 10Show fewer
- Patients who receive concurrent neuraxial anesthesia (spinal, epidural, or indwelling pain pumps)
- Patients who receive concurrent local anesthetic drips planned during or administered immediately after surgery
- Patients who have a contraindication to local anesthetics (e.g. verified allergy, severe hepatic dysfunction)
- Patients who use chronic narcotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
About this study
Official title: Laparoscopic Assisted Plane Block (LAPB) Trial: Bupivacaine Versus Liposomal Bupivacaine Versus Standard Local Anesthesia for Post-operative Analgesia
This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.
Read the detailed description
Patients will either be pre-screened prior to their pre-operative appointment for eligibility, or screening will occur on the day of surgery. Informed Consent will be obtained from amenable, eligible patients prior to their operation by a member of the research team. A study number will be assigned, and the patient will be randomized to a treatment group. The patients will not be aware to which treatment group they have been randomized.
After consent is obtained and randomization has been completed, the operating room registered nurse will calculate maximum dose of allowable bupivacaine per patient based on body weight. Anesthesia will provide the intravenous lidocaine bolus on induction to all patients without a contraindication to the medication. The port placement will occur using a needle to raise skin/preperitoneal wheal*. Up to 20cc of 1% lidocaine/epinephrine will be divided among all ports and stab incisions. At end of case, no further skin or port-specific preperitoneal anesthetic will be injected unless a skin incision was extended.
For patients randomized to port site injection (Control): 60 cc of sterile, preservative-free, injectable saline will be given as a placebo per the protocol in item 6.
For patients randomized to bupivacaine plain LAPB (Treatment Arm 1): The maximum weight-based dose of plain bupivacaine will be diluted with sterile, injectable, preservative-free saline to a total of 60cc with a maximum of 250mg bupivacaine (regardless of weight) and loaded into a 30cc syringe with a 22g spinal needle (one 30cc syringe used for each side).
For patients randomized to liposomal bupivacaine LAPB (Treatment Arm 2): The maximum dose for adult patients is 266mg (20mL) of liposomal bupivacaine. This will be diluted with 40cc of preservative-free normal saline for injection, per manufacturer recommendations. The solution will then be loaded into a 30cc syringe with a 22g spinal needle and injected in the same fashion as the bupivacaine plain LAPB.
Data collection will include total doses of IV and skin and block anesthetic used, patient weight, number and size of ports, if fascial closure of port site was conducted, and post-operative narcotic medication used up to 48 hours with timing and doses marked, and use of any pain adjuncts (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen, gabapentin, tricyclic antidepressants [TCA], pregabalin, clonidine, etc.) although doses of these medications are not to be recorded.
Provision of home narcotic prescription will be based on a standardized protocol developed by Dartmouth. Based on the past 24 hours of pain medication usage, patients will receive either 15 or 30 tablets of hydrocodone/acetaminophen 5/325mg (or liquid equivalent for bariatric patients). Use of narcotic medications at home will be evaluated at 1 week post-procedure by a member of the research team through a phone survey.
- Conditions
- Opioid Use
- Being tested
- Bupivacaine, Exparel 266 milligram Per 20 ML Injection, Saline
- Keywords
- post-operative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
utilizing local anesthetic to perform a regional block under laparoscopic guidance
Exparel 266 milligram Per 20 ML InjectionDrug
Also called Exparel, liposomal bupivacaine
utilizing local anesthetic to perform a regional block under laparoscopic guidance
SalineDrug
Also called Injectable Saline
placebo injection of saline
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine block | Active comparator | laparoscopic assisted plane block of standardized dose of bupivacaine plain Receives: Drug: Bupivacaine |
| liposomal bupivacaine block (Exparel 266 milligram Per 20 ML) | Active comparator | laparoscopic assisted plane block of standardized dose of bupivacaine plain Receives: Drug: Exparel 266 milligram Per 20 ML Injection |
| saline block | Placebo comparator | laparoscopic assisted plane block with placebo saline injection Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Usage
post-operative narcotic usage expressed in morphine equivalents
Measured: 24 hours
Secondary outcomes (4)
Narcotic Usage
post-operative narcotic usage expressed in morphine equivalents
Measured: 7 days
Pain Scores
Visual Analog Score for pain (1-10)
Measured: 24 hours
Post-Operative Nausea
Post-operative nausea will be quantified through chart review by recording the amount of anti-emetic medication administered in the 24 hour period the patient is admitted post-operatively. This will allow objective quantification of nausea in the immediate post-operative period for analysis.
Measured: 24 hours
Post-operative emesis
Emesis is recorded as part of the standard intake/output medical charting, and the number of episodes of emesis will be quantified from chart review. This will be analyzed between groups to determine if the intervention has an impact on the number of episodes of post-operative emesis.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start4 Feb 2019
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Why it stopped: There were not enough attendings/residents working on the study throughout the COVID-19 pandemic in order to enroll the number of patients required to meet statistical significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Barbara Cottage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Zerey, MD, Principal investigator, Cottage Hospital, Sansum Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730402
- Sponsor's protocol ID
- 18-66mr
- Status last verified
- Jun 2021
- First submitted
- 2 Nov 2018
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Plane Block (LAPB) Trial: Bupivacaine Versus Liposomal Bupivacaine Versus Standard Local Anesthesia for Post-operative Analgesia
- ClinicalTrials.gov ID
- NCT03730402
- Acronym / sponsor ID
- 18-66mr
- Conditions
- Opioid Use
- Keywords
- post-operative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were not enough attendings/residents working on the study throughout the COVID-19 pandemic in order to enroll the number of patients required to meet statistical significance.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Santa Barbara Cottage HospitalUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 5 Nov 2018 (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.
This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.
Detailed description
Patients will either be pre-screened prior to their pre-operative appointment for eligibility, or screening will occur on the day of surgery. Informed Consent will be obtained from amenable, eligible patients prior to their operation by a member of the research team. A study number will be assigned, and the patient will be randomized to a treatment group. The patients will not be aware to which treatment group they have been randomized.
After consent is obtained and randomization has been completed, the operating room registered nurse will calculate maximum dose of allowable bupivacaine per patient based on body weight. Anesthesia will provide the intravenous lidocaine bolus on induction to all patients without a contraindication to the medication. The port placement will occur using a needle to raise skin/preperitoneal wheal*. Up to 20cc of 1% lidocaine/epinephrine will be divided among all ports and stab incisions. At end of case, no further skin or port-specific preperitoneal anesthetic will be injected unless a skin incision was extended.
For patients randomized to port site injection (Control): 60 cc of sterile, preservative-free, injectable saline will be given as a placebo per the protocol in item 6.
For patients randomized to bupivacaine plain LAPB (Treatment Arm 1): The maximum weight-based dose of plain bupivacaine will be diluted with sterile, injectable, preservative-free saline to a total of 60cc with a maximum of 250mg bupivacaine (regardless of weight) and loaded into a 30cc syringe with a 22g spinal needle (one 30cc syringe used for each side).
For patients randomized to liposomal bupivacaine LAPB (Treatment Arm 2): The maximum dose for adult patients is 266mg (20mL) of liposomal bupivacaine. This will be diluted with 40cc of preservative-free normal saline for injection, per manufacturer recommendations. The solution will then be loaded into a 30cc syringe with a 22g spinal needle and injected in the same fashion as the bupivacaine plain LAPB.
Data collection will include total doses of IV and skin and block anesthetic used, patient weight, number and size of ports, if fascial closure of port site was conducted, and post-operative narcotic medication used up to 48 hours with timing and doses marked, and use of any pain adjuncts (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen, gabapentin, tricyclic antidepressants [TCA], pregabalin, clonidine, etc.) although doses of these medications are not to be recorded.
Provision of home narcotic prescription will be based on a standardized protocol developed by Dartmouth. Based on the past 24 hours of pain medication usage, patients will receive either 15 or 30 tablets of hydrocodone/acetaminophen 5/325mg (or liquid equivalent for bariatric patients). Use of narcotic medications at home will be evaluated at 1 week post-procedure by a member of the research team through a phone survey.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- prospective randomized control trial
| Arm | Type | Receives |
|---|---|---|
| bupivacaine block | Active comparator | Drug: Bupivacainelaparoscopic assisted plane block of standardized dose of bupivacaine plain |
| liposomal bupivacaine block (Exparel 266 milligram Per 20 ML) | Active comparator | Drug: Exparel 266 milligram Per 20 ML Injectionlaparoscopic assisted plane block of standardized dose of bupivacaine plain |
| saline block | Placebo comparator | Drug: Salinelaparoscopic assisted plane block with placebo saline injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years old
- Patients undergoing non-emergent laparoscopic surgery with planned or continued admission for at least 1 night
- Patients who receive fully laparoscopic procedures including ports up to 15mm, and any blunt dilation of port fascia or sharp extension of skin incisions for specimen extraction.
Key exclusion criteria (10 listed)
- Patients under 18 or over 80 years old
- Patients who are pregnant
- Patients who are unable to consent themselves
- Patients who undergo an appendectomy for acute appendicitis
- Patients who undergo emergent surgery
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 |
|---|---|---|
| BupivacaineAlso: Marcaineutilizing local anesthetic to perform a regional block under laparoscopic guidance | Drug | bupivacaine block |
| Exparel 266 milligram Per 20 ML InjectionAlso: Exparel, liposomal bupivacaineutilizing local anesthetic to perform a regional block under laparoscopic guidance | Drug | liposomal bupivacaine block (Exparel 266 milligram Per 20 ML) |
| SalineAlso: Injectable Salineplacebo injection of saline | Drug | saline block |
Primary outcome
Narcotic Usage
Time frame: 24 hours
post-operative narcotic usage expressed in morphine equivalents
4 secondary outcomes
Narcotic Usage
Time frame: 7 days
Pain Scores
Time frame: 24 hours
Post-Operative Nausea
Time frame: 24 hours
Post-operative emesis
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: There were not enough attendings/residents working on the study throughout the COVID-19 pandemic in order to enroll the number of patients required to meet statistical significance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- 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.
Marc Zerey, MD principal investigator
Cottage Hospital, Sansum Clinic
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 Bupivacaine, Exparel 266 milligram Per 20 ML Injection and Saline in people with Opioid Use, run by Santa Barbara Cottage Hospital 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: stopped early, as of the sponsor's last update on 1 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: There were not enough attendings/residents working on the study throughout the COVID-19 pandemic in order to enroll the number of patients required to meet statistical significance.). Results are not available in the source record.
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?
Narcotic Usage (time frame: 24 hours). 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 1 Jul 2021.