Phase 4
Completed N=24
TAP-patients With Robotic Assisted Lap Prostatectomy
Postsurgical Pain · Analgesia · Prostatectomy
Source: ClinicalTrials.gov NCT01582477 ↗
Enrolled (actual)
24
Serious AEs
12.5%
Results posted
Jun 2013
Primary outcomePrimary: The Duration of Abdominal Analgesia From Infiltration Into the TAP — 0.39; 0.44 hours
Summary
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Duration of Abdominal Analgesia From Infiltration Into the TAP |
0.39; 0.44 | — |
| SECONDARY Subject Reported Postsurgical Pain |
4.4; 5.3; 3.1; 3.9; 2.4; 3.0 | — |
| SECONDARY Physician/Healthcare Professional Assessed Postsurgical Pain |
4.2; 5.3; 2.9; 3.9; 2.4; 3.0 | — |
| SECONDARY Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. |
1.9; 2.2; 2.8; 3.4; 3.7; 4.8 | — |
| SECONDARY Incidence of Prespecified Opioid-related Adverse Events |
0; 0 | — |
| SECONDARY Overall Rating of Subject Satisfaction With Postsurgical Pain Control |
4; 5; 8; 7; 4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- male subjects, aged 18-75.
- American Society of Anesthesiology (ASA) physical status 1-3.
- Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.
Exclusion Criteria
- Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
- Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP.
- Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- Subjects who have received any investigational drug within 30 days prior to study drug administration or planned administration of another investigational product or procedure during their participation in this study.
Data sourced from ClinicalTrials.gov (NCT01582477). 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.