EUCTR2017-004593-34-DK
Active, not recruiting
Phase 1
ltrasound-guided Transmuscular Quadratus Lumborum block for Laparoscopic Hysterectomy. A double blind, randomized, placebo controlled trial
Zealand University Hospital Roskilde0 sites70 target enrollmentJanuary 2, 2018
ConditionsThe postoperative pain and morphine consumption after Total Laparoscopic HysterectomyMedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsRopivacaine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The postoperative pain and morphine consumption after Total Laparoscopic Hysterectomy
- Sponsor
- Zealand University Hospital Roskilde
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants in the study should fullfil the following criteria in order to be included:
- •\-Scheduled for TLH
- •\-Age \> 17 years at the date of inclusion
- •Have received thorough information, orally and in written, and signed the Informed Consent” form on participation in the trial
- •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 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Either of the following criteria will lead to exclusion of the patient of the study:
- •Inability to cooperate
- •Inability to speak, read and understand Danish
- •Allergy to local anaesthetics or opioids
- •Daily intake of opioids, according to the investigators decision
- •Local infection at the site of injection or systemic infection
- •Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
- •Co\-morbidity, ASA\>3
Outcomes
Primary Outcomes
Not specified
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