Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702685
• Other study ID #: ESP1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2021
• Est. completion date: August 2021

Study information

• Verified date: December 2020
• Source: Nazarbayev University Medical Center
• Contact: Dmitry Viderman, MD
• Phone: +77055426716
• Email: dmitry.viderman[@]nu.edu.kz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
Local anesthetic for injection

Other:
• Placebo
Bandage will be placed in the presumed injection site while patients in under general anesthesia

Locations

Country	Name	City	State
Kazakhstan	National Center for Oncology	Astana

Sponsors (2)

Lead Sponsor	Collaborator
Nazarbayev University Medical Center	National Research Oncology and Transplantology Center, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Time to discharge	From time of surgery completion to discharge from hospital	Expected time to discharge is up to 2 weeks
Secondary	Usage of NSAIDs post surgery	Dose	Total dose used during the 24 hour period after surgery.