Pain, PostoperativeNCT03927326
Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration
A study testing Exparel 266 MG Per 20 ML Injection in people with Pain, Postoperative and Anesthesia, Local, run by University of Washington.
Trial summary
This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Local, Anesthesia; Functional
- What is being tested?
- Exparel 266 MG Per 20 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jul 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay
Who cannot join
- Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
- Patients allergic to bupivacaine
- Patients with ASA status IV, V, or VI
- Patients unable to consent
- Patients that are pregnant
- Patients that are incarcerated
- Patients receiving procedures in addition to laparoscopic colorectal procedure
- Patients on systemic anticoagulation precluding them from regional blocks
Trial locations and contacts
No sites are listed yet.
About this study
Official title: On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration
This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.
Read the detailed description
Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.
A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.
- Being tested
- Exparel 266 MG Per 20 ML Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 266 MG Per 20 ML InjectionDrug
Liposomal bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration | Experimental | Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites. Receives: Drug: Exparel 266 MG Per 20 ML Injection |
| Transversus abdominis plane block | Experimental | Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block. Receives: Drug: Exparel 266 MG Per 20 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour post operative opioid consumption
Listed in morphine daily equivalents.
Measured: 24 hours postoperative
Secondary outcomes (5)
12 hour post operative opioid consumption
Listed in morphine daily equivalents
Measured: 12 hours postoperative
48 hour post operative opioid consumption
Listed in morphine daily equivalents
Measured: 48 hours postoperative
Pain intensity at 12 hours post operative
Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
Measured: 12 hours
Pain intensity at 24 hours post operative
Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
Measured: 24 hours
Hospital length of stay
How long the patient requires their inpatient stay measured in days.
Measured: Until end of hospital stay, typically 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study startAug 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Chang, University of Washington
- Investigators
- Vanessa Loland, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927326
- Sponsor's protocol ID
- STUDY00007182
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning on making IPD available to other researchers.
Publications
Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
PubMed 22570563Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
PubMed 22067185Mulligan RP, Morash JG, DeOrio JK, Parekh SG. Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty. Foot Ankle Int. 2017 Nov;38(11):1222-1228. doi: 10.1177/1071100717722366. Epub 2017 Aug 8.
PubMed 28786304Sternlicht A, Shapiro M, Robelen G, Vellayappan U, Tuerk IA. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical analgesia in robotic laparoscopic prostatectomy: a pilot study. Local Reg Anesth. 2014 Dec 12;7:69-74. doi: 10.2147/LRA.S64515. eCollection 2014.
PubMed 25540595Hadzic A, Abikhaled JA, Harmon WJ. Impact of volume expansion on the efficacy and pharmacokinetics of liposome bupivacaine. Local Reg Anesth. 2015 Dec 7;8:105-11. doi: 10.2147/LRA.S88685. eCollection 2015.
PubMed 26673040Candiotti KA, Sands LR, Lee E, Bergese SD, Harzman AE, Marcet J, Kumar AS, Haas E. Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes. Curr Ther Res Clin Exp. 2013 Dec 27;76:1-6. doi: 10.1016/j.curtheres.2013.12.001. eCollection 2014 Dec.
PubMed 25031661Gastevski D. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical pain management in a 39-year-old female undergoing laparoscopic cholecystectomy. Pain Med. 2014 Aug;15(8):1312-5. doi: 10.1111/pme.12356. Epub 2014 Jan 21.
PubMed 24612211
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration
- ClinicalTrials.gov ID
- NCT03927326
- Acronym / sponsor ID
- STUDY00007182
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Apr 2019 (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 evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.
Detailed description
Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.
A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Unblinded randomized trial
| Arm | Type | Receives |
|---|---|---|
| Local infiltration | Experimental | Drug: Exparel 266 MG Per 20 ML InjectionLiposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites. |
| Transversus abdominis plane block | Experimental | Drug: Exparel 266 MG Per 20 ML InjectionLiposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay
Key exclusion criteria (8 listed)
- Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
- Patients allergic to bupivacaine
- Patients with ASA status IV, V, or VI
- Patients unable to consent
- Patients that are pregnant
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 |
|---|---|---|
| Exparel 266 MG Per 20 ML InjectionLiposomal bupivacaine | Drug | Local infiltration, Transversus abdominis plane block |
Primary outcome
24 hour post operative opioid consumption
Time frame: 24 hours postoperative
Listed in morphine daily equivalents.
5 secondary outcomes
12 hour post operative opioid consumption
Time frame: 12 hours postoperative
48 hour post operative opioid consumption
Time frame: 48 hours postoperative
Pain intensity at 12 hours post operative
Time frame: 12 hours
Pain intensity at 24 hours post operative
Time frame: 24 hours
Hospital length of stay
Time frame: Until end of hospital stay, typically 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Background: PubMed 22570563Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
- Background: PubMed 22067185Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
- Background: PubMed 28786304Mulligan RP, Morash JG, DeOrio JK, Parekh SG. Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty. Foot Ankle Int. 2017 Nov;38(11):1222-1228. doi: 10.1177/1071100717722366. Epub 2017 Aug 8.
- Background: PubMed 25540595Sternlicht A, Shapiro M, Robelen G, Vellayappan U, Tuerk IA. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical analgesia in robotic laparoscopic prostatectomy: a pilot study. Local Reg Anesth. 2014 Dec 12;7:69-74. doi: 10.2147/LRA.S64515. eCollection 2014.
- Background: PubMed 26673040Hadzic A, Abikhaled JA, Harmon WJ. Impact of volume expansion on the efficacy and pharmacokinetics of liposome bupivacaine. Local Reg Anesth. 2015 Dec 7;8:105-11. doi: 10.2147/LRA.S88685. eCollection 2015.
- Background: PubMed 25031661Candiotti KA, Sands LR, Lee E, Bergese SD, Harzman AE, Marcet J, Kumar AS, Haas E. Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes. Curr Ther Res Clin Exp. 2013 Dec 27;76:1-6. doi: 10.1016/j.curtheres.2013.12.001. eCollection 2014 Dec.
- Background: PubMed 24612211Gastevski D. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical pain management in a 39-year-old female undergoing laparoscopic cholecystectomy. Pain Med. 2014 Aug;15(8):1312-5. doi: 10.1111/pme.12356. Epub 2014 Jan 21.
- Individual participant dataSharing planned: No. We are not planning on making IPD available to other researchers.
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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.
Vanessa Loland, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Exparel 266 MG Per 20 ML Injection in people with Pain, Postoperative and Anesthesia, Local, run by University of Washington.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Chang, MD (714-878-0850, achang5@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour post operative opioid consumption (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927326, which also lists 7 linked publications.
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 25 Apr 2019.