Phase 4
Completed N=50
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Source: ClinicalTrials.gov NCT03802864 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Pain Scores 48 Hours After Surgery — 118.4; 98.2 Scores*Hour — p=0.41
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores 48 Hours After Surgery |
118.4; 98.2 | 0.41 |
| SECONDARY Pain Scores 60 Hours After Surgery |
140.7; 116 | 0.37 |
| SECONDARY Pain Scores 7 Days After Surgery |
286.6; 233.1 | 0.36 |
| SECONDARY Narcotic Requirement |
2.6; 1.6 | 0.28 |
| SECONDARY Time to Narcotic Rescue |
10; 8; 0; 0; 0; 3 | 0.78 |
| SECONDARY Pain Control Satisfaction |
22; 20; 0; 1 | 0.49 |
| SECONDARY Percentage of Patients Not Requiring Any Narcotics |
15; 16; 10; 9 | 0.99 |
Eligibility Criteria
Inclusion Criteria
- Men scheduled for surgical sperm retrieval for infertility
- Men 18 years and older who can provide informed consent
- No documented allergy to bupivacaine or celecoxib
Exclusion Criteria
- Prior history of substance abuse
- Any narcotic use within the last 3 months
- Concomitant use of aspirin
- Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
- Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Data sourced from ClinicalTrials.gov (NCT03802864). 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.