Use of Perioperative Pain Blocks In Urological Surgery
Condition: Pain, Postoperative; Nerve Block; Robotic Surgical Procedures
MeSH terms: Pain, Postoperative
Intervention: Bupivacain; Ultrasound-guided transversus abdominus plane block; Laparoscopic-guided transversus abdominus plane block
Intervention description: Direct injection of 0.25% bupivacaine into surgical wounds; bilateral TAP using ultrasound guidance in prostatectomies; bilateral TAP using laparoscopic guidance in prostatectomies
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Masking description: 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.
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase III; Randomized; Single blind; Single Center; Three arm; Non-inferiority

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.
    

Eligibility criteria:

        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