Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery

Study Overview
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Brief Summary
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This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.

Official Title
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Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial

Conditions
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Liver Surgery

Intervention / Treatment
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* Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament
* Procedure: Thoracic epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years ASA I-III Open liver surgery Exclusion Criteria: Contraindication to nerve block or epidural puncture Chronic use of opioids or NSAIDs Refused to participate in the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus lumborum block<br>Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament. | Procedure: Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament<br>* Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.<br>|
| Active Comparator: Thoracic epidural analgesia<br>Thoracic epidural analgesia at the level of T7-10. | Procedure: Thoracic epidural analgesia<br>* A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (numeric rating scale) score for coughing pain | Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain) | at 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score for rest and coughing pain | Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain) | at 1, 6, 24, 48, 72 hours after surgery | 
| consumption of opioid converted to IV morphine equivalents | opioids given postoperatively converted to IV morphine equivalents | during 24 hours after surgery | 
| Numbers of additional analgesics | Additional rescue analgesics were used when pain relief was inadequate (NRS >3). The choice of rescue analgesic was oxydone 5-10mg. | during 72 hours after surgery | 
| The incidence of postoperative hypotension | Adverse reactions related to analgesia | during 72 hours after surgery | 
| The incidence of nausea and vomiting | Adverse reactions related to analgesia | during 72 hours after surgery | 
| The incidence of pruritus | Adverse reactions related to analgesia | during 72 hours after surgery | 
| The incidence of respiratory depression | Adverse reactions related to analgesia | during 72 hours after surgery | 
| Time to ambulation in days | Postoperative ambulation time | through study completion, an average of 2-3 days | 
| Time to eat in days | Time to start eating after surgery | through study completion, an average of 2-3 days | 
| Time to flatus in hours | Time to flatus after surgery | through study completion, an average of 40-50 hours | 
| Time to defecation in hours | Time to defecation after surgery | through study completion, an average of 60-70 hours | 
| Time to urethral catheter removal in hours | Time tourethral catheter removal after surgery | through study completion, an average of 60-70 hours | 
| Postoperative hospital stay in days | The time from operation to discharge | through study completion, an average of 7-8 days | 
| Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication | Postoperative Clavien-Dindo complication classification | One month after surgery |