Colorectal SurgeryPhase 3NCT03702621

Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

A Phase 3 study testing liposomal Bupivacaine and Bupivacaine Hydrochloride in people with Colorectal Surgery, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Surgery
What is being tested?: liposomal Bupivacaine and Bupivacaine Hydrochloride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2018to 13 Mar 2020
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing colorectal surgery at Indiana University Hospital
American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4
Age 18 or older, male or female
Desires Regional anesthesia for postoperative pain control

Who cannot join

Any contraindication for QL block.
History of substance abuse in the past 6 months.
Patients on more than 30mg morphine equivalents of opioids daily.
Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
Postoperative intubation.
Any BMI greater than 40.0.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery

Read the detailed description

Quadratus lumborum (QL) blocks will be done intraoperatively after induction. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.

All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively. Patients above 70yo will receive 300mg gabapentin. Patient will be randomized to one of the two arms.

For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. For the liposomal bupivacaine (LB) group, 0.125% bupivacaine 20ml plus Exparel®10ml will then be injected into the fascial plane on each side. For the standard bupivacaine (SB) group. 30ml 0.25% bupivacaine will be injected on each side. Saline will be used for hydro-dissection until the QL block target is confirmed on ultrasound.

As part of the enhanced recovery after surgery (ERAS) protocol, all patients will receive ketamine and lidocaine drip during surgery, which is the investigator's current standard of practice.

All patients will be scheduled on PO acetaminophen and PO gabapentin daily postoperatively per ERAS protocol. PO oxycodone as needed (PRN) will be started once patients tolerate diet. PRN IV dilaudid may be given for severe breakthrough pain.

Opioid usage at 1, 24, 48 and 72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the QL block and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.

Conditions: Colorectal Surgery
Being tested: liposomal Bupivacaine, Bupivacaine Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liposomal BupivacaineDrug
20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group
Bupivacaine HydrochlorideDrug
40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.
60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group

Study groups in NCT03702621
Study group	Role	What they receive
Liposomal Bupivacaine	Active comparator	LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Receives: Drug: liposomal Bupivacaine
Standard Bupivacaine	Active comparator	SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Receives: Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

VAS Score at 1 Hour at Rest
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 1 hour after surgery
VAS Score at 1 Hour With Movement
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 1 hour after surgery
VAS Score at 24 Hours at Rest
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 24 hours after surgery
VAS Score at 24 Hours With Movement
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 24 hours after surgery
VAS Score at 48 Hours at Rest
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 48 hours after surgery
VAS Score at 48 Hours With Movement
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 48 hours after surgery
VAS Score at 72 Hours at Rest
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 72 hours after surgery
VAS Score at 72 Hours With Movement
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Measured: Pain scores will be measured 72 hours after surgery

Secondary outcomes (4)

Total Opioid Consumption at 1 Hour
Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Measured: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded
Total Opioid Consumption at 24 Hour
Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Measured: Opioid consumption will be measured at 24 hour post op. The total amount will be recorded
Total Opioid Consumption at 48 Hour
Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Measured: Opioid consumption will be measured at 48 hour post op. The total amount will be recorded
Total Opioid Consumption at 72 Hour
Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements
Measured: Opioid consumption will be measured at 72 hour post op. The total amount will be recorded

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 201813 Mar 2020

First posted11 Oct 2018
Study start30 Aug 2018
Primary completion13 Mar 2020
Study completion13 Mar 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1. LB group (Liposomal Bupivacaine) 2. SB group (Standard Bupivacaine)
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03702621
Sponsor's protocol ID: 1806187876
Status last verified: May 2023
First submitted: 6 Aug 2018
Last updated: 17 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Yeap YL, Wolfe J, Stewart J, McCutchan A, Chawla G, Robb B, Holcomb B, Vickery B. Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. Pain Manag. 2022 Jan;12(1):35-43. doi: 10.2217/pmt-2021-0033. Epub 2021 Sep 23.
PubMed 34551581

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery
ClinicalTrials.gov ID: NCT03702621
Acronym / sponsor ID: 1806187876
Conditions: Colorectal Surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 30 Aug 2018 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 13 Mar 2020 (actual)
First posted: 11 Oct 2018 (actual)
Results: Posted 17 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery

Detailed description

Quadratus lumborum (QL) blocks will be done intraoperatively after induction. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.

All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively. Patients above 70yo will receive 300mg gabapentin. Patient will be randomized to one of the two arms.

As part of the enhanced recovery after surgery (ERAS) protocol, all patients will receive ketamine and lidocaine drip during surgery, which is the investigator's current standard of practice.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: 1. LB group (Liposomal Bupivacaine) 2. SB group (Standard Bupivacaine)

Arm	Type	Receives
Liposomal Bupivacaine	Active comparator	Drug: liposomal BupivacaineLB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.
Standard Bupivacaine	Active comparator	Drug: Bupivacaine HydrochlorideSB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing colorectal surgery at Indiana University Hospital
American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4
Age 18 or older, male or female
Desires Regional anesthesia for postoperative pain control

Key exclusion criteria (7 listed)

Any contraindication for QL block.
History of substance abuse in the past 6 months.
Patients on more than 30mg morphine equivalents of opioids daily.
Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).

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
liposomal Bupivacaine20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group	Drug	Liposomal Bupivacaine
Bupivacaine Hydrochloride40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group	Drug	Standard Bupivacaine

Primary outcome

VAS Score at 1 Hour at Rest
Time frame: Pain scores will be measured 1 hour after surgery
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 1 Hour With Movement
Time frame: Pain scores will be measured 1 hour after surgery
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 24 Hours at Rest
Time frame: Pain scores will be measured 24 hours after surgery
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 24 Hours With Movement
Time frame: Pain scores will be measured 24 hours after surgery
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 48 Hours at Rest
Time frame: Pain scores will be measured 48 hours after surgery
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 48 Hours With Movement
Time frame: Pain scores will be measured 48 hours after surgery
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 72 Hours at Rest
Time frame: Pain scores will be measured 72 hours after surgery
The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 72 Hours With Movement
Time frame: Pain scores will be measured 72 hours after surgery
The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

4 secondary outcomes

Total Opioid Consumption at 1 Hour
Time frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded
Total Opioid Consumption at 24 Hour
Time frame: Opioid consumption will be measured at 24 hour post op. The total amount will be recorded
Total Opioid Consumption at 48 Hour
Time frame: Opioid consumption will be measured at 48 hour post op. The total amount will be recorded
Total Opioid Consumption at 72 Hour
Time frame: Opioid consumption will be measured at 72 hour post op. The total amount will be recorded

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposomal Bupivacaine	44	38
Standard Bupivacaine	46	40

Primary outcome: VAS Score at 1 Hour at Rest

Time frame: Pain scores will be measured 1 hour after surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine n = 38	Standard Bupivacaine n = 40
Value	5.0 (0.0 to 7.0)	3.0 (0.0 to 6.0)

Liposomal Bupivacaine vs Standard Bupivacaine: p = 0.54, Mixed Models Analysis

Primary outcome: VAS Score at 1 Hour With Movement

Time frame: Pain scores will be measured 1 hour after surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine n = 38	Standard Bupivacaine n = 40
Value	5.0 (0.0 to 8.0)	3.0 (0.0 to 6.0)

Liposomal Bupivacaine vs Standard Bupivacaine: p = 0.59, Mixed Models Analysis

Primary outcome: VAS Score at 24 Hours at Rest

Time frame: Pain scores will be measured 24 hours after surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine n = 38	Standard Bupivacaine n = 40
Value	4.0 (2.0 to 6.0)	3.0 (2.0 to 5.5)

Liposomal Bupivacaine vs Standard Bupivacaine: p = 0.98, Mixed Models Analysis

Primary outcome: VAS Score at 24 Hours With Movement

Time frame: Pain scores will be measured 24 hours after surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Liposomal Bupivacaine n = 38	Standard Bupivacaine n = 40
Value	7.0 (4.0 to 9.0)	6.0 (3.0 to 8.0)

Liposomal Bupivacaine vs Standard Bupivacaine: p = 0.94, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 72 hours postoperative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Standard Bupivacaine	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34551581Yeap YL, Wolfe J, Stewart J, McCutchan A, Chawla G, Robb B, Holcomb B, Vickery B. Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. Pain Manag. 2022 Jan;12(1):35-43. doi: 10.2217/pmt-2021-0033. Epub 2021 Sep 23.

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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.

Yar Yeap, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liposomal Bupivacaine and Bupivacaine Hydrochloride in people with Colorectal Surgery, run by Indiana University 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 4 inclusion and 7 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 17 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 May 2023). 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?

VAS Score at 1 Hour at Rest (time frame: Pain scores will be measured 1 hour after surgery). The study lists 8 primary outcomes in all. 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 NCT03702621, which also lists 1 linked publication.

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 17 May 2023.