Use of Perioperative Pain Blocks In Urological Surgery

Mount Sinai Health System

Status and phase: Completed; Phase 3

Conditions: Nerve Block; Pain, Postoperative; Robotic Surgical Procedures

Treatments: Drug: Ultrasound-guided transversus abdominus plane block; Drug: Laparoscopic-guided transversus abdominus plane block; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT04426500

GCO 19-1532

NCI-2019-08790 (Registry Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 3 patient groups, including a placebo group

Placebo/Local Anesthesia

Placebo Comparator group

Description:

Direct injection of 0.25% bupivacaine into surgical wounds

Treatment:

Drug: Bupivacain

Ultrasound-guided transversus abdominus plane (UTAP) block

Active Comparator group

Description:

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).

Treatment:

Drug: Bupivacain

Drug: Ultrasound-guided transversus abdominus plane block

Laparoscopic-guided transversus abdominus plane (LTAP) block

Experimental group

Description:

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).

Treatment:

Drug: Bupivacain

Drug: Laparoscopic-guided transversus abdominus plane block