Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
Phase 4
- Conditions
- Wounds
- Registration Number
- NCT00737425
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief Summary
The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Subject's Age ≥ 18
- Subject is able, agrees and signs the Informed Consent Form
- Subject requires laparoscopic-assisted abdominal surgery
- Incision size following the laparoscopy between 4-7 cm
Exclusion Criteria
- Epidural analgesia
- IV PCA
- Subject has any condition, which precludes compliance with study and/or device instructions
- Subject is currently participating in another clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain and discomfort will be measured using appropriate validated questionnaires. Pain assessment will be performed daily
- Secondary Outcome Measures
Name Time Method Infections will be assessed by concomitant antibiotic intake Concomitant medications will be assessed daily
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie PainShield's efficacy in postoperative wound healing and pain relief for laparoscopic-assisted abdominal surgery (NCT00737425)?
How does the PainShield device compare to standard-of-care analgesics in managing postoperative pain after laparoscopic abdominal surgery (NCT00737425)?
Which biomarkers predict response to ultrasound-based analgesia in postoperative wound healing for laparoscopic-assisted abdominal surgery (NCT00737425)?
What adverse events are associated with the PainShield device in laparoscopic-assisted abdominal surgery patients (NCT00737425) and their management strategies?
What combination therapies or competitor devices enhance postoperative pain relief when used with the PainShield in laparoscopic-assisted abdominal surgery (NCT00737425)?
Trial Locations
- Locations (1)
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center🇮🇱Jerusalem, Israel