ltrasoundguided quadratus lumborum block after removal of the gallbladder. A randomised clinical trial

Conditions: Postoperative pain following laparoscopic cholecystectomy
MedDRA version: 16.1Level: LLTClassification code 10049890Term: CholecystolithiasisSystem Organ Class: 100000004871
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-001364-30-DK

Lead Sponsor: Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients for planned laparoscopic cholecystectomy
Painscore >= 4 NRS upon arrival in recovery
Recieved verbal as well as written information about the trial
Informed consent signed
Age > 18 yrs
ASA 1-3

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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cannot cooperate to the procedure
Does not speak or understand danish
Allergy towards the medicine used in the trail
Large daily consumption of opioids
Known abuse of alcohol og medication
Difficult or impossible procedure due to anatomical conditions

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare ultrasound guided transmuscular quadrates lumborum block with placebo in patients undergoing laparoscopic cholecystectomy. Main objective is pain score sititng up 1 hour after administration of block.;Secondary Objective: Opioid consumption<br>LOS in recovery<br>Pain intensity in prone position;Primary end point(s): Pain intensity sitting up;Timepoint(s) of evaluation of this end point: 1 hour after performing the blockprocedure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain intensity in prone position<br>Opioid consumption (total)<br>Opioid sideeffects<br>LOS in recovery;Timepoint(s) of evaluation of this end point: 15 min, 30 min, 2 h and every hour until discharge to home<br>Total consumption until discharge<br>Occurence of nausea and/or vomiting<br>Time until discharge criteria met in recovery regardless of logistics