Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Study Overview
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Brief Summary
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Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.

Detailed Description
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The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.

Official Title
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A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy). Males or females 18-70 years of age American Society of Anesthesiologists physical status class I,II, III Signed informed consent Exclusion Criteria: Patients undergoing emergency surgery Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies) Comorbid obesity (BMI≥35kg/m2) Anomalies of vertebral column Use of anticoagulants and patients with hypocoagulable conditions Pregnancy Physician preference for therapeutic anticoagulation Infection of skin at site of needle puncture Known allergies to study drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance | Drug: Ropivacaine<br>* Local anesthetic for injection<br>* Other names: Naropin;|
| Placebo Comparator: Placebo<br>No injection. Bandage will be placed over the presumed site of injection | Other: Placebo<br>* Bandage will be placed in the presumed injection site while patients in under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cumulative opioid consumption up to 24 hours after surgery | Cumulative opioid consumption will be recorded for 24 hours following surgery | 24 hours post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain score | Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used | Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery. | 
| Time to ambulation | The time that the patient is able to walk independently, after surgery | Between surgery and discharge from hospital, expected time is between 1 day to 1 week | 
| Time to discharge | From time of surgery completion to discharge from hospital | Expected time to discharge is up to 2 weeks | 
| Usage of NSAIDs post surgery | Dose | Total dose used during the 24 hour period after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ropivacaine, major upper abdominal surgery, supraumbilical, liver resection, colon resection, Whipple procedure, gastrectomy, anesthetics, local, erector spinae plane block