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

Nazarbayev University Medical Center1 site in 1 country50 target enrollmentJanuary 2021

ConditionsPain, Postoperative

InterventionsRopivacaine Placebo

DrugsRopivacaine

Overview

Phase: Phase 3
Intervention: Ropivacaine
Conditions: Pain, Postoperative
Sponsor: Nazarbayev University Medical Center
Enrollment: 50
Locations: 1
Primary Endpoint: Mean cumulative opioid consumption up to 24 hours after surgery
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 2021

End Date

August 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nazarbayev University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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
•Physician preference for therapeutic anticoagulation
•Infection of skin at site of needle puncture
•Known allergies to study drugs

Arms & Interventions

Ropivacaine

Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance

Intervention: Ropivacaine

Placebo

No injection. Bandage will be placed over the presumed site of injection

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

Post-operative pain score(Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.)
Time to ambulation(Between surgery and discharge from hospital, expected time is between 1 day to 1 week)
Time to discharge(Expected time to discharge is up to 2 weeks)
Usage of NSAIDs post surgery(Total dose used during the 24 hour period after surgery.)