Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder. The trial will compare active TQL block versus placebo TQL block after said operation. The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.

Official Title
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Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.

Conditions
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Cholecystitis, Pain

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective laparoscopic cholecystectomy received oral and written information about the trial American Society of Anaethesiologists (ASA) classification 1-3 NRS score > 3 upon arrival at the PACU area Exclusion Criteria: Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol og medicin abuse Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo TQL block<br>30 ml single shot TQL block with saline 0,9% | Drug: saline<br> <br> |
| Active Comparator: Active TQL block<br>30 ml single shot TQL block with ropivacaine 0,75% | Drug: Ropivacaine<br> <br> * Other names: naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score in sitting position | Numerical Rating Scale (NRS) score 1 hour after administration of TQL block | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at rest | NRS score after administration of TQL block at said time points | 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour | 
| Pain score at sitting position | NRS score after administration of TQL block at said time points | 15 min 30 min 2 hour 3 hour 4 hour 5 hour | 
| Total opioid consumption in PACU area | During stay in PACU area | On average 3 hours | 
| Opioid side effects (nausea, vomiting) | During stay in PACU area | On average 3 hours | 
| Length of stay in PACU area | Total time in PACU area | On average 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic, Cholecystectomy, Postoperative, Quadratus lumborum, Ultrasound, Pain