Continuous TQL Block for Elective Cesarean Section

Study Overview
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Brief Summary
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The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.

Official Title
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Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.

Conditions
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Postoperative Pain, Anesthesia, Local

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years of age. Scheduled for elective Caesarean Section in spinal anaesthesia. Have received thorough information, verbally and in written, and signed the Informed Consent form on participation in the trial. Exclusion Criteria: Inability to cooperate Inability to understand Danish Allergy to local anaesthetics or opioids Excessive daily intake of opioids, according to the discretion of the investigator Local infection at the site of injection or systemic infection Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Active Comparator: Intervention<br>Ropivacaine | Drug: Ropivacaine<br>* 2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour<br>|
| Placebo Comparator: Control<br>Isotonic saline | Drug: Saline<br>* 2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first opioid | The time from catheters placement to the administration of opioids | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity (NRS 0-10/10) | NRS (numeric rating scale) score in the study period at 3, 6, 9, 12 and 24 hours postoperatively. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the Patient-Controlled Analgesia (PCA) pump display prior to administration of the PCA boluses. NRS is a pain scale where the patient gives her pain a number from 0-10, where 0 is no pain and 10 is the worst pain imaginable. | 24 hours postoperatively | 
| Total morphine consumption. | Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record). | 24 hours | 
| Catheter displacement. | Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)). | 24 hours | 
| Patient satisfaction with application of the catheters. | NRS 0-10/10 during placement of catheters | 24 hours | 
| The degree of morphine-related side effects (PONV, itching, fatigue, etc.). | On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe. | 24 hours | 
| Time from operation to ambulation. | Time from operation to ambulation. | 24 hours |