Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kazakhstan
  • Astana, Kazakhstan
    • National Center for Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Nazarbayev University Medical Center
• Collaborators: National Research Oncology and Transplantology Center, Kazakhstan
• Investigators: Principal Investigator: Philip la Fleur, RPh MSc, philip.lafleur@nu.edu.kz

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (ACTUAL): January 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: ropivacaine; gastrectomy; liver resection; erector spinae plane block; colon resection; Whipple procedure; major upper abdominal surgery; supraumbilical; anesthetics, local
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: ESP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, we will share information with other researchers.
• IPD Sharing Time Frame: Q3 and Q4 2021
• IPD Sharing Access Criteria: Researchers on staff at an accredited university
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No