Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Overview

Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: May 2021

Detailed Description

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.

Interventions

  • Drug: Ropivacaine
    • Local anesthetic for injection
  • Other: Placebo
    • Bandage will be placed in the presumed injection site while patients in under general anesthesia

Arms, Groups and Cohorts

  • Experimental: Ropivacaine
    • Ropivacaine 0.5% – 20 ml will be administered as erector spinae plane block under ultrasound guidance
  • Placebo Comparator: Placebo
    • No injection. Bandage will be placed over the presumed site of injection

Clinical Trial Outcome Measures

Primary Measures

  • Mean cumulative opioid consumption up to 24 hours after surgery
    • Time Frame: 24 hours post-operation
    • Cumulative opioid consumption will be recorded for 24 hours following surgery

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. 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). 2. Males or females 18-70 years of age 3. American Society of Anesthesiologists physical status class I,II, III 4. Signed informed consent Exclusion Criteria:

1. Patients undergoing emergency surgery 2. Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies) 3. Comorbid obesity (BMI≥35kg/m2) 4. Anomalies of vertebral column 5. Use of anticoagulants and patients with hypocoagulable conditions 6. Pregnancy 7. Physician preference for therapeutic anticoagulation 8. Infection of skin at site of needle puncture 9. Known allergies to study drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nazarbayev University Medical Center
  • Collaborator
    • National Research Oncology and Transplantology Center, Kazakhstan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philip la Fleur, RPh MSc, Principal Investigator, philip.lafleur@nu.edu.kz
  • Overall Contact(s)
    • Dmitry Viderman, MD, +77055426716, dmitry.viderman@nu.edu.kz

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