Use of Perioperative Pain Blocks In Urological Surgery

Phase 3

Completed

Conditions: Pain, Postoperative
Nerve Block
Robotic Surgical Procedures

Interventions: Drug: Bupivacain
Drug: Ultrasound-guided transversus abdominus plane block
Drug: Laparoscopic-guided transversus abdominus plane block

Registration Number: NCT04426500

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 148

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/Local Anesthesia	Bupivacain	Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane (UTAP) block	Ultrasound-guided transversus abdominus plane 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).
Laparoscopic-guided transversus abdominus plane (LTAP) block	Bupivacain	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).
Laparoscopic-guided transversus abdominus plane (LTAP) block	Laparoscopic-guided transversus abdominus plane 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).
Ultrasound-guided transversus abdominus plane (UTAP) block	Bupivacain	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).

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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 Outcome Measures

Name	Time	Method
Intraoperative Ketoralac Use	up to 420 minutes	Intraoperative Ketoralac Use
Intraoperative Time and Block Time	up to 420 minutes	Intraoperative time taken to complete surgical blocks and operative
Postoperative Narcotic Use	24 hours post operatively	Postoperative Narcotic Use in morphine equivalents
Total Analgesic Medications	24 hours post operatively	The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.
Intraoperative Narcotic Use	up to 420 minutes	Intraoperative Narcotic Use in morphine equivalents
The Amount of Ondansetron Use	2 weeks	Use of antiemetic medications during the postoperative course
Number of Days to Return of Bowel Function	2 weeks	Number of days to the return of bowel function
The Length of Hospital Stay	2 weeks	Length of hospital stay from time of surgical completion to time of discharge.
VAS in Obese Patients	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	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).