Group 3 for Postoperative Pain

The University of Kansas Health System, Kansas City, KS
Postoperative Pain+1 More ConditionsBupivacaine Hydrochloride - Drug
All Sexes
What conditions do you have?

Study Summary

This trialcompares how well different anesthetics reduce pain and opioid use after skin grafts for partial or full thickness burns.

Eligible Conditions
  • Postoperative Pain
  • Burns

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. They will be compared between two groups.

Day 3
Opioid pain medication consumption up to 72 hours post-operatively will be compared between the subjects who are given liposomal bupivacaine (Exparel) and lidocaine at the donor sites
Hour 72
Pain Scores over 72 hours after surgery
Hour 8
A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3 Treatment Groups

Group 2
1 of 3
Group 3
1 of 3
Group 1
1 of 3

Active Control

Experimental Treatment

75 Total Participants · 3 Treatment Groups

Primary Treatment: Group 3 · No Placebo Group · Phase 4

Group 3
Experimental Group · 1 Intervention: Bupivacaine Hydrochloride · Intervention Types: Drug
Group 1
Experimental Group · 1 Intervention: Liposomal bupivacaine · Intervention Types: Drug
Group 2
ActiveComparator Group · 1 Intervention: Lidocaine Hydrochloride · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Hydrochloride
Completed Phase 4
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pain scores associated with skin graft donor site will be assessed using visual analog scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. they will be compared between two groups.

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
412 Previous Clinical Trials
160,638 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What primary ailments can Group 1 be applied to?

"Group 1 treatments are frequently used to treat minor burns, but they can also provide relief from lupus erythematosus cell, ulcerative colitis and transplantation." - Anonymous Online Contributor

Unverified Answer

What security measures can be taken to ensure Group 1 is not a hazard for people?

"As this is a phase 4 trial, which signals a treatment's approval, our team at Power gave Group 1 an assessment of 3 on the safety scale." - Anonymous Online Contributor

Unverified Answer

How many volunteers are currently partaking in this clinical experiment?

"Indeed. According to, this study posted on March 18th 2019 is still enrolling patients and was recently updated on December 28th 2022. 75 participants are needed at the single site hosting the trial." - Anonymous Online Contributor

Unverified Answer

Are there still open slots available for this research endeavor?

"Affirmative. indicates that this investigation, which was published on March 18th 2019, is currently seeking participants. An estimated 75 people need to be enrolled from 1 center of care." - Anonymous Online Contributor

Unverified Answer

What further research has been conducted concerning Group 1?

"At present, 40 trials for Group 1 are in the third phase of development. Furthermore, 192 active studies exist within this group and 1203 locations across Germantown, Tennessee have been conducting these tests." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.