Use of Perioperative Pain Blocks In Urological Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426500
• Other study ID #: GCO 19-1532
• Secondary ID: NCI-2019-08790
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2019
• Est. completion date: February 13, 2021

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 13, 2021
• Est. primary completion date: February 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Robotic Surgical Procedures

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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;: — View Citation

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. — View Citation

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. — View Citation

Outcome

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