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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04702685

Enrollment

Registered

2021-01-11

Start date

2021-01-31

Completion date

2021-08-31

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

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

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.

Interventions

DRUGRopivacaine

Local anesthetic for injection

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Bandage with tape will be placed over the presumed site of anesthetic injection

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Kazakhstan

Contacts

Primary ContactDmitry Viderman, MD

dmitry.viderman@nu.edu.kz+77055426716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026