Use of Perioperative Pain Blocks In Urological Surgery

Overview

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.

Full Title of Study: “Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 13, 2021

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.

Interventions

  • Drug: Bupivacain
    • Direct injection of 0.25% bupivacaine into surgical wounds
  • Drug: Ultrasound-guided transversus abdominus plane block
    • bilateral TAP using ultrasound guidance in prostatectomies
  • Drug: Laparoscopic-guided transversus abdominus plane block
    • bilateral TAP using laparoscopic guidance in prostatectomies

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo/Local Anesthesia
    • Direct injection of 0.25% bupivacaine into surgical wounds
  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Intraoperative Time and Block Time
    • Time Frame: up to 420 minutes
    • Intraoperative time taken to complete surgical blocks and operative
  • Intraoperative Narcotic Use
    • Time Frame: up to 420 minutes
    • Intraoperative Narcotic Use in morphine equivalents
  • Intraoperative Ketoralac Use
    • Time Frame: up to 420 minutes
    • Intraoperative Ketoralac Use
  • Postoperative Narcotic Use
    • Time Frame: 24 hours post operatively
    • Postoperative Narcotic Use in morphine equivalents
  • 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.
  • The Amount of Ondansetron Use
    • Time Frame: 2 weeks
    • Use of antiemetic medications during the postoperative course
  • Number of Days to Return of Bowel Function
    • Time Frame: 2 weeks
    • Number of days to the return of bowel function
  • The Length of Hospital Stay
    • Time Frame: 2 weeks
    • Length of hospital stay from time of surgical completion to time of discharge.
  • 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
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reza Mehrazin, Assistant Professor, Urologic Oncology – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • Reza Mehrazin, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai

References

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;:

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.