Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine; Other: Placebo

• Registration Number: NCT04702685
• Lead Sponsor: Nazarbayev University Medical Center

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-03
• Study Start: 2021-01
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-05
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine	Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance
Placebo	Placebo	No injection. Bandage will be placed over the presumed site of injection

Primary Outcome Measures

Name	Time	Method
Mean cumulative opioid consumption up to 24 hours after surgery	24 hours post-operation	Cumulative opioid consumption will be recorded for 24 hours following surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative pain score	Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.	Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used
Time to ambulation	Between surgery and discharge from hospital, expected time is between 1 day to 1 week	The time that the patient is able to walk independently, after surgery
Time to discharge	Expected time to discharge is up to 2 weeks	From time of surgery completion to discharge from hospital
Usage of NSAIDs post surgery	Total dose used during the 24 hour period after surgery.	Dose

Trial Locations

Locations (1)

National Center for Oncology; 🇰🇿 Astana, Kazakhstan