Improving pain management after Laparoscopic Hysterectomy with regional anaesthesia

Phase 1

• Conditions: The postoperative pain and morphine consumption after Total Laparoscopic Hysterectomy; MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-004593-34-DK
• Lead Sponsor: Zealand University Hospital Roskilde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Aim:<br> Our aim with this study is to investigate the efficacy of the Ultrasound-guided (USG) Transmuscular Quadratus Lumborum (TQL) block vs. Placebo in patients undergoing Total Laparoscopic Hysterectomy (TLH).<br> Our hypothesis is that the bilateral TQL block will significantly reduce the opioid consumption during the first 12 postoperative hours.<br><br> ;Secondary Objective: Our hypothesis is that the bilateral TQL block will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10), opioid related side effects, times to first opioid and times to ambulation.;<br> Primary end point(s): The primary outcome of the study will be:<br> Morphine consumption in the first 12 postoperative hours (data from PCA pump and the patient’s medical record).<br> ;Timepoint(s) of evaluation of this end point: Twelve hours after arrival at the Post Anesthesia Care Unit (PACU)