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Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.
The first phase of the study was a randomized controlled study. In the second phase, all subjects will receive fascia iliaca, lateral femoral cutaneous, or femoral nerve blocks based on the proposed donor site location and will be compared to historic controls from the first phase. In the first phase, the control group underwent split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. In the first phase, the experimental group underwent injection of liposomal bupivacaine (Exparel) at the time of harvest of the skin graft. In the second phase, patients will undergo preoperative regional anesthesia with a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location rather than the standard protocol of lidocaine with epinephrine at the donor site. Thus, in the second phase, group 3 (preoperative block group) will be compared to historic controls which received the standard of care in the first phase of this trial. Baseline pain levels will be obtained for all subjects using a validated pain assessment scale, the Visual Analog Pain Scale. Postoperatively, time to first opioid pain medication (excluding immediate postoperative recovery from anesthesia), total opioid consumption on a daily basis, and donor site interval pain scores using a validated pain assessment scale will be obtained. The experimental groups will then be individually compared to the control group to determine if there is a significant difference in pain levels, time to first opioid, and overall opioid consumption between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting |
|
| Group 2 | Active Comparator | Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting |
|
| Group 3 | Experimental | Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Hydrochloride | Drug | Injected subcutaneously for skin graft harvesting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A Measurement of Post Operative Pain Involving Skin Graft Donor Site Using Visual Analog Scale (VAS) Ranging 0-10, at 8 Hours Post-operatively | Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine | The subject completes a pain assessment at 8 hours post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents | 72 hours (3 days) post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Health System | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34216466 | Derived | Egan KG, Guest R, Sinik LM, Nazir N, De Ruyter M, Ponnuru S, Bhavsar D. Evaluation of Liposomal Bupivacaine at Split-Thickness Skin Graft Donor Sites Through a Randomized, Controlled Trial. J Burn Care Res. 2021 Nov 24;42(6):1280-1285. doi: 10.1093/jbcr/irab129. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting |
| FG001 | Group 2 | Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting |
| FG002 | Group 3 | Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients underwent skin grating surgery for full thickness burn injury.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Measurement of Post Operative Pain Involving Skin Graft Donor Site Using Visual Analog Scale (VAS) Ranging 0-10, at 8 Hours Post-operatively | Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine | Each group was planned for 25 subjects. We only enrolled 24 in the regional anesthesia group as we were able to achieve statistical significance at that number and did not require another subject to participate at that time. | Posted | Mean | Standard Deviation | score on a scale 0-10 | The subject completes a pain assessment at 8 hours post-operatively. |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dhaval Bhavsar | University of Kansas Medical Center | 9135882000 | dbhavsar@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 | Aug 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D002056 | Burns |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group
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Only subjects in first phase will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future.
| Liposomal bupivacaine |
| Drug |
Injected subcutaneously for skin graft harvesting |
|
|
| Bupivacaine Hydrochloride | Drug | Used for regional nerve block for skin graft harvesting |
|
| Pain Scores Over 72 Hours After Surgery |
Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine |
| Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 72 hours after surgery. They will be compared between the groups. |
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting |
| BG002 | Group 3 | Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2 | Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting |
| OG002 | Group 3 | Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting |
|
|
| Secondary | 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 | Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents | Posted | Mean | Standard Deviation | MME | 72 hours (3 days) post operatively |
|
|
|
| Secondary | Pain Scores Over 72 Hours After Surgery | Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine | Posted | Mean | Standard Deviation | Pain score 1-10 | Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 72 hours after surgery. They will be compared between the groups. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Group 2 | Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Group 3 | Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting | 0 | 24 | 0 | 24 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|