Use of Perioperative Pain Blocks In Urological Surgery

NCT04426500 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: GCO 19-1532NCI-2019-08790
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Nerve Block; Robotic Surgical Procedures

Keywords

Phase III; Randomized; Single blind; Single Center; Three arm; Non-inferiority

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Intraoperative Time and Block Time

  up to 420 minutes

• Intraoperative Narcotic Use

  up to 420 minutes

• Intraoperative Ketoralac Use

  up to 420 minutes

• Postoperative Narcotic Use

  24 hours post operatively

• Total Analgesic Medications

  24 hours post operatively

Study Arms (3)

Placebo/Local Anesthesia

PLACEBO COMPARATOR

Direct injection of 0.25% bupivacaine into surgical wounds

Drug: Bupivacain

Ultrasound-guided transversus abdominus plane (UTAP) block

ACTIVE COMPARATOR

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).

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

Laparoscopic-guided transversus abdominus plane (LTAP) block

EXPERIMENTAL

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).

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

Interventions

Bupivacain DRUG

Direct injection of 0.25% bupivacaine into surgical wounds

Also known as: Local anesthesia

Laparoscopic-guided transversus abdominus plane (LTAP) block; Placebo/Local Anesthesia; Ultrasound-guided transversus abdominus plane (UTAP) block

Ultrasound-guided transversus abdominus plane block DRUG

bilateral TAP using ultrasound guidance in prostatectomies

Also known as: UTAP

Ultrasound-guided transversus abdominus plane (UTAP) block

Laparoscopic-guided transversus abdominus plane block DRUG

bilateral TAP using laparoscopic guidance in prostatectomies

Also known as: LTAP

Laparoscopic-guided transversus abdominus plane (LTAP) block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (4)

• 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.

  PMID: 22902793 BACKGROUND

• 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.

  PMID: 24860252 BACKGROUND

• 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.

  PMID: 27733219 BACKGROUND

• 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.

  PMID: 30056612 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

This trial reflected the practice of a busy academic tertiary care center. There were numerous anesthesiologists performing the UTAP and the choice of intraoperative anesthetic and medications given was uncontrolled. In addition, multiple surgeons accrued patients to the trial with variances in operative technique. This heterogeneity among anesthesiologists and surgeons does introduce confounders but also lends to the generalizability of the present study.

Results Point of Contact

• Title: Dr. Reza Mehrazin
• Organization: Icahn School of Medicine at Mount Sinai

reza.mehrazin@mountsinai.org

(212) 241-4812

Study Officials

• Reza Mehrazin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A randomization service called Sealedenvelope.com available at https://www.sealedenvelope.com/simple-randomiser/v1/ will be used for allocation concealment to ensure that retrieval of the treatment group assignment is only revealed to appropriate team members on a real time basis after each new patient has been screened and consented. This service allows for allocation concealment that would not be possible if the entire randomization list was made available to team members at the beginning of the study. The security and integrity of the codes used by Sealedenvelope.com follows the Food and Drug Administration (FDA) standards for electronic records and follows the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines. Participants will be blinded to group allocation throughout the study. Due to the nature of the intervention, it is not possible to blind the investigator to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Urologic Oncology

Model Details: This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio. People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: November 11, 2019
• Primary Completion: February 13, 2021
• Study Completion: February 13, 2021
• Last Updated: March 12, 2024
• Results First Posted: May 6, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)