Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Nazarbayev University Medical Center

Status and phase: Unknown; Phase 3

Conditions: Pain, Postoperative

Treatments: Other: Placebo; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04702685

ESP1

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo