Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

NCT04702685 | Unknown Phase 3

• 1 other identifier: ESP1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

ropivacaine; major upper abdominal surgery; supraumbilical; liver resection; colon resection; Whipple procedure; gastrectomy; anesthetics, local; erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ropivacaine DRUG

Local anesthetic for injection

Also known as: Naropin

Ropivacaine

Placebo OTHER

Bandage will be placed in the presumed injection site while patients in under general anesthesia

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nazarbayev University Medical Center: lead
• National Research Oncology and Transplantology Center, Kazakhstan: collaborator

Study Sites (1)

National Center for Oncology

Astana, Kazakhstan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Philip la Fleur, RPh MSc

  philip.lafleur@nu.edu.kz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Viderman, MD

CONTACT

+77055426716; dmitry.viderman@nu.edu.kz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Bandage with tape will be placed over the presumed site of anesthetic injection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 11, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Q3 and Q4 2021
• Access Criteria: Researchers on staff at an accredited university

Locations

KA (1)