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To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL Block | Active Comparator | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
|
| TAP Block | Active Comparator | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL Block | Procedure | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score | NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative. | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cumulative Opioids | opiate consumption first 72 hours post operatively | 72 hours |
| Number of Participants With Nausea or Emesis Requiring Antiemetic Medication | Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | QL Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| FG001 | TAP Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QL Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Average Pain Score | NRS patient reported (number rated pain score, 0=no pain - 10=highest pain) over the first 24 hours post operative. | Posted | Mean | Standard Deviation | score on a scale | 24 hours post operative |
|
0-24 hours post operative
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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 | QL Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. QL Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Bolin, MD | Medical University of South Carolina | 8437921869 | bolin@musc.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 | Apr 17, 2019 | Jun 12, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2019 | Jun 12, 2020 | ICF_001.pdf |
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Prospective randomized double-blinded trial to compare TAP block versus QL block for pain management in living donor nephrectomy patients. Participants will be blinded to the type of block received and physicians will be blinded both intra- and post-op regarding which block patients received. The team who performs the block will know which block the patient received. No one else involved in the care of the patient will know. The surgery team will not know, and the primary (in the OR) anesthesia team will not know. None of the providers involved in post-operative care of the patient will know.
| TAP Block | Procedure | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
|
| 24 hours |
| Number of Participants With Block Related Complications | 24 hours |
| Length of Stay in Post Anesthesia Care Unit (PACU) | Duration of PACU stay. | 24 hours |
| Length of Hospital Stay | The time from surgery completion to subject meeting discharge criterion. | 3 days |
| BG001 | TAP Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
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| Secondary | Total Cumulative Opioids | opiate consumption first 72 hours post operatively | Posted | Mean | Standard Deviation | morphine milligram equivalents (MME) | 72 hours |
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| Secondary | Number of Participants With Nausea or Emesis Requiring Antiemetic Medication | Antiemetics given in PACU. Occurrence of nausea or emesis requiring antiemetic medication administration in PACU. | Posted | Count of Participants | Participants | 24 hours |
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| Secondary | Number of Participants With Block Related Complications | Posted | Count of Participants | Participants | 24 hours |
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| Secondary | Length of Stay in Post Anesthesia Care Unit (PACU) | Duration of PACU stay. | Posted | Mean | Standard Deviation | minutes | 24 hours |
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| Secondary | Length of Hospital Stay | The time from surgery completion to subject meeting discharge criterion. | Posted | Mean | Standard Deviation | days | 3 days |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | TAP Block | Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. TAP Block: Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc. | 0 | 24 | 0 | 24 | 0 | 24 |
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