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Phase 3 Completed N=148 Randomized Single-blind Supportive Care

Use of Perioperative Pain Blocks In Urological Surgery

Pain, Postoperative · Nerve Block · Robotic Surgical Procedures
Source: ClinicalTrials.gov NCT04426500 ↗
Enrolled (actual)
148
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Visual Analog Scale (VAS) — 1.29; 3.16; 2.89 score on a scale
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Scale (VAS)
1.29; 3.16; 2.89
SECONDARY
Intraoperative Time and Block Time
2.5; 6.0; 2.5; 211.5; 224.5; 221
SECONDARY
Intraoperative Narcotic Use
27.0; 24.1; 25.5
SECONDARY
Intraoperative Ketoralac Use
0; 0; 15
SECONDARY
Postoperative Narcotic Use
14.13; 19.50; 17
SECONDARY
Total Analgesic Medications
1650; 1650; 1325; 0; 30; 0
SECONDARY
The Amount of Ondansetron Use
0.05; 0.31; 0.29
SECONDARY
Number of Days to Return of Bowel Function
SECONDARY
The Length of Hospital Stay
SECONDARY
VAS in Obese Patients
1.29; 4.09; 2.33; 1.29; 2.67; 3.00
SECONDARY
Number of Procedure Related Complications
0; 0; 0

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04426500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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