- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426500
Use of Perioperative Pain Blocks In Urological Surgery
Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Undergoing Robotic Assisted Laparoscopic Partial Nephrectomy or Robotic Assisted Laparoscopic Prostatectomy
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Prior Partial Nephrectomy or Subtotal Prostatectomy Surgery (organ specific)
- Conversion to open surgery
- History of chronic pain
- History of opiate or alcohol dependence
- Allergies to local anesthetic
- Retroperitoneal surgery
- Single Port Surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo/Local Anesthesia
Direct injection of 0.25% bupivacaine into surgical wounds
|
Direct injection of 0.25% bupivacaine into surgical wounds
Other Names:
|
Active Comparator: Ultrasound-guided transversus abdominus plane (UTAP) block
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).
|
Direct injection of 0.25% bupivacaine into surgical wounds
Other Names:
bilateral TAP using ultrasound guidance in prostatectomies
Other Names:
|
Experimental: Laparoscopic-guided transversus abdominus plane (LTAP) block
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).
|
Direct injection of 0.25% bupivacaine into surgical wounds
Other Names:
bilateral TAP using laparoscopic guidance in prostatectomies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 24 hours post operatively
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative Time and Block Time
Time Frame: up to 420 minutes
|
Intraoperative time taken to complete surgical blocks and operative
|
up to 420 minutes
|
Intraoperative Narcotic Use
Time Frame: up to 420 minutes
|
Intraoperative Narcotic Use in morphine equivalents
|
up to 420 minutes
|
Intraoperative Ketoralac Use
Time Frame: up to 420 minutes
|
Intraoperative Ketoralac Use
|
up to 420 minutes
|
Postoperative Narcotic Use
Time Frame: 24 hours post operatively
|
Postoperative Narcotic Use in morphine equivalents
|
24 hours post operatively
|
Total Analgesic Medications
Time Frame: 24 hours post operatively
|
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
Time Frame: 2 weeks
|
Use of antiemetic medications during the postoperative course
|
2 weeks
|
Number of Days to Return of Bowel Function
Time Frame: 2 weeks
|
Number of days to the return of bowel function
|
2 weeks
|
The Length of Hospital Stay
Time Frame: 2 weeks
|
Length of hospital stay from time of surgical completion to time of discharge.
|
2 weeks
|
VAS in Obese Patients
Time Frame: 24 hours post operatively
|
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
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Reza Mehrazin, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: J Robot Surg. 2018 Aug 14;:
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 19-1532
- NCI-2019-08790 (Registry Identifier: National Cancer Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Bupivacain
-
University Hospital Inselspital, BerneCompletedUrinary Retention | Analgesia, Epidural | UrodynamicsSwitzerland
-
Basaksehir Cam & Sakura Şehir HospitalRecruitingAnesthesia, Local | Post Operative Pain | Fracture of Hip | QoR-15Turkey
-
Assiut UniversityNot yet recruiting
-
Sisli Hamidiye Etfal Training and Research HospitalCompleted
-
Benha UniversityCompletedPostoperative PainEgypt
-
Ankara City Hospital BilkentNot yet recruitingHip Fractures | Spinal Anesthesia
-
University Tunis El ManarRecruitingPostoperative Pain | Analgesia | Anesthesia, Local | Mandible FractureTunisia
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalEnrolling by invitation
-
Istanbul UniversityNot yet recruiting
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalRecruitingPostoperative PainTurkey