Phase 3
N=148
Use of Perioperative Pain Blocks In Urological Surgery
Pain, Postoperative · Nerve Block · Robotic Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT04426500 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Visual Analog Scale (VAS) — 1.29; 3.16; 2.89 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bupivacain (Drug); Ultrasound-guided transversus abdominus plane block (Drug); Laparoscopic-guided transversus abdominus plane block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-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 | — |
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
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.