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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08790 | Registry Identifier | National Cancer Institute |
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The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic blocks) are being employed for the care of urological surgery patients. Local and regional anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be challenging, particularly in larger, obese patients. It is unknown how such techniques compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall, potentially allowing for greater ease of access from a laparoscopic approach from within than the ultrasound guided percutaneous approach.
Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15) vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014 compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with decreased accrual secondary to a surgeon taking a leave of absence during the study period. Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2) vs. 4 (2-6)) on the VAS score, respectively.
A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).
The most recent study, done in 2018, examined 100 randomized patients undergoing robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).
While all of these studies point to potential efficacy of UTAP, no data has been published to date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided administration. While these regional anesthetic blocks carry a theoretical risk of hematoma or damage to surrounding structures, none of the above studies report any complications with the injections.
The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Local Anesthesia | Placebo Comparator | Direct injection of 0.25% bupivacaine into surgical wounds |
|
| Ultrasound-guided transversus abdominus plane (UTAP) block | Active Comparator | 30mL of 0.25% bupivacaine will be administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). |
|
| Laparoscopic-guided transversus abdominus plane (LTAP) block | Experimental | 30mL of 0.25% bupivacaine will be administered to bilateral TAP using laparoscopic guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | Direct injection of 0.25% bupivacaine into surgical wounds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain | 24 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Time and Block Time | Intraoperative time taken to complete surgical blocks and operative | up to 420 minutes |
| Intraoperative Narcotic Use | Intraoperative Narcotic Use in morphine equivalents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Mehrazin, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22902793 | Background | Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697. | |
| 24860252 | Background | Aniskevich S, Taner CB, Perry DK, Robards CB, Porter SB, Thomas CS, Logvinov II, Clendenen SR. Ultrasound-guided transversus abdominis plane blocks for patients undergoing laparoscopic hand-assisted nephrectomy: a randomized, placebo-controlled trial. Local Reg Anesth. 2014 May 25;7:11-6. doi: 10.2147/LRA.S61589. eCollection 2014. |
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196 patients were eligible for the study and initially randomized. A total of 143 prostatectomy patients were deemed appropriate candidates for the trial and randomized and 114 participants were then enrolled.
A total of 53 partial nephrectomy patients were deemed appropriate candidates for the trial. 34 participants were randomized and then enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Local Anesthesia | Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure. |
| FG001 | Ultrasound-guided Transversus Abdominus Plane (UTAP) Block | 30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies |
| FG002 | Robotic -Guided Transversus Abdominus Plane (RTAP) Block | 30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic -Guided Transversus Abdominus Plane (RTAP) Block | 30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies |
| 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 | Visual Analog Scale (VAS) | Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain | Posted | Mean | Standard Deviation | score on a scale | 24 hours post operatively |
|
2 weeks
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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/Local Anesthesia | Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure. |
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This trial reflected the practice of a busy academic tertiary care center. There were numerous anesthesiologists performing the UTAP and the choice of intraoperative anesthetic and medications given was uncontrolled. In addition, multiple surgeons accrued patients to the trial with variances in operative technique. This heterogeneity among anesthesiologists and surgeons does introduce confounders but also lends to the generalizability of the present study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reza Mehrazin | Icahn School of Medicine at Mount Sinai | (212) 241-4812 | reza.mehrazin@mountsinai.org |
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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 | Jan 7, 2020 | Feb 11, 2022 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio.
People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.
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A randomization service called Sealedenvelope.com available at https://www.sealedenvelope.com/simple-randomiser/v1/ will be used for allocation concealment to ensure that retrieval of the treatment group assignment is only revealed to appropriate team members on a real time basis after each new patient has been screened and consented. This service allows for allocation concealment that would not be possible if the entire randomization list was made available to team members at the beginning of the study. The security and integrity of the codes used by Sealedenvelope.com follows the Food and Drug Administration (FDA) standards for electronic records and follows the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines.
Participants will be blinded to group allocation throughout the study. Due to the nature of the intervention, it is not possible to blind the investigator to group allocation.
|
| Ultrasound-guided transversus abdominus plane block | Drug | bilateral TAP using ultrasound guidance in prostatectomies |
|
|
| Laparoscopic-guided transversus abdominus plane block | Drug | bilateral TAP using laparoscopic guidance in prostatectomies |
|
|
| up to 420 minutes |
| Intraoperative Ketoralac Use | Intraoperative Ketoralac Use | up to 420 minutes |
| Postoperative Narcotic Use | Postoperative Narcotic Use in morphine equivalents | 24 hours post operatively |
| Total Analgesic Medications | The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents. | 24 hours post operatively |
| The Amount of Ondansetron Use | Use of antiemetic medications during the postoperative course | 2 weeks |
| Number of Days to Return of Bowel Function | Number of days to the return of bowel function | 2 weeks |
| The Length of Hospital Stay | Length of hospital stay from time of surgical completion to time of discharge. | 2 weeks |
| VAS in Obese Patients | 24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI >30 and BMI<30 | 24 hours post operatively |
| Number of Procedure Related Complications | Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0). | 2 weeks |
| 27733219 | Background | Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4. |
| 30056612 | Background | Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28. |
| BG001 | Ultrasound-guided Transversus Abdominus Plane (UTAP) Block | 30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies |
| BG002 | Placebo/Local Anesthesia | Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Surgical Procedure | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| OG002 | Robotic -Guided Transversus Abdominus Plane (RTAP) Block | 30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies |
|
|
| Secondary | Intraoperative Time and Block Time | Intraoperative time taken to complete surgical blocks and operative | Posted | Median | Full Range | minutes | up to 420 minutes |
|
|
|
| Secondary | Intraoperative Narcotic Use | Intraoperative Narcotic Use in morphine equivalents | Posted | Mean | Standard Deviation | morphine equivalents | up to 420 minutes |
|
|
|
| Secondary | Intraoperative Ketoralac Use | Intraoperative Ketoralac Use | Posted | Median | Full Range | mg | up to 420 minutes |
|
|
|
| Secondary | Postoperative Narcotic Use | Postoperative Narcotic Use in morphine equivalents | Posted | Median | Full Range | morphine equivalents | 24 hours post operatively |
|
|
|
| Secondary | Total Analgesic Medications | The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents. | Posted | Median | Full Range | mg morphine equivalents | 24 hours post operatively |
|
|
|
| Secondary | The Amount of Ondansetron Use | Use of antiemetic medications during the postoperative course | Posted | Mean | Standard Deviation | mg | 2 weeks |
|
|
|
| Secondary | Number of Days to Return of Bowel Function | Number of days to the return of bowel function | Data not collected. | Posted | 2 weeks |
|
|
| Secondary | The Length of Hospital Stay | Length of hospital stay from time of surgical completion to time of discharge. | Data not collected. | Posted | 2 weeks |
|
|
| Secondary | VAS in Obese Patients | 24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI >30 and BMI<30 | participants divided by BMI >30 and BMI <30 | Posted | Mean | Standard Deviation | score on a scale | 24 hours post operatively |
|
|
|
| Secondary | Number of Procedure Related Complications | Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0). | Posted | Number | events | 2 weeks |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Ultrasound-guided Transversus Abdominus Plane (UTAP) Block | 30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies | 0 | 64 | 0 | 64 | 0 | 64 |
| EG002 | Robotic -Guided Transversus Abdominus Plane (RTAP) Block | 30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting). Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies | 0 | 56 | 0 | 56 | 0 | 56 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| Male |
|
|
|
|
| Ondansetron |
|
| BMI <30 |
|
|