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| Name | Class |
|---|---|
| Halyard Health | INDUSTRY |
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The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy
This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.
Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.
This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group (TAP-S) | Placebo Comparator | (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter |
|
| Active Group (TAP-C) | Active Comparator | (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP-C | Device | TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Narcotic Usage at 48 Hours | The primary endpoint of this study will be narcotic requirement at 48 hours | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours | All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point. | up to 60 hours |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yar Yeap, MD | Indiana University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19020158 | Background | Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313. | |
| 18165577 | Background | McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group (TAP-S) | (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
| FG001 | Active Group (TAP-C) | (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group (TAP-S) | (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
| 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 | Total Narcotic Usage at 48 Hours | The primary endpoint of this study will be narcotic requirement at 48 hours | Posted | Mean | Standard Error | mg | 48 hours |
|
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Serious and other adverse events were not monitored/addressed.
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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 | Placebo Group (TAP-S) | (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yar Yeap | Indiana University School of Medicine - Anesthesia Division | 317-274-0275 | yyeap@iupui.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| TAP-S | Drug | Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case. |
|
|
| Average Pain Scores | Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged. | up to 60 hours |
| Nausea Scores at 48 Hours | Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe. | up to 48 hours |
| Sedation Scores at 48 Hours | Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep. | 48 hours |
| 17179269 | Background | McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. |
| 32198963 | Result | Yeap YL, Wolfe JW, Kroepfl E, Fridell J, Powelson JA. Transversus abdominis plane (TAP) block for laparoscopic live donor nephrectomy: Continuous catheter infusion provides no additional analgesic benefit over single-injection ropivacaine. Clin Transplant. 2020 Jun;34(6):e13861. doi: 10.1111/ctr.13861. Epub 2020 Apr 9. |
| BG001 | Active Group (TAP-C) | (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Active Group (TAP-C) | (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen |
|
|
| Secondary | Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours | All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point. | Posted | Mean | Standard Error | mg | up to 60 hours |
|
|
|
| Secondary | Average Pain Scores | Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged. | Posted | Mean | Standard Error | units on a scale | up to 60 hours |
|
|
|
| Secondary | Nausea Scores at 48 Hours | Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe. | Posted | Mean | Standard Error | units on a scale | up to 48 hours |
|
|
|
| Secondary | Sedation Scores at 48 Hours | Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep. | Posted | Mean | Standard Error | units on a scale | 48 hours |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Active Group (TAP-C) | (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case Oxycodone/Acetaminophen | 0 | 0 | 0 | 0 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |