Status:
UNKNOWN
Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery
Lead Sponsor:
Nazarbayev University Medical Center
Collaborating Sponsors:
National Research Oncology and Transplantology Center, Kazakhstan
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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, tim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04702685
Start Date
January 1 2021
End Date
August 1 2021
Last Update
January 11 2021
Active Locations (1)
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1
National Center for Oncology
Astana, Kazakhstan