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Intraperitoneal atomization of levobupivacaine during gynecological laparoscopic procedures : Impact on pain, opioid use and length of recovery room stay (IPLA).

Phase 1
Conditions
Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis.
MedDRA version: 14.1Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2013-000384-87-BE
Lead Sponsor
Ghent University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
60
Inclusion Criteria

- Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Less than 18 year old
- Weight less than 50 kg and more than 80 kg
- Pregnant
- Prisoners
- Allergic to topical anesthetics (Amides specifically)
- Allergic to Opioids as a class
- Currently or within the last 30 days been prescribed an opiate medication
- Chronic pain syndrome

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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