Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Ropivacaine

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Local anesthetic for injection

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Ropivacaine

Local anesthetic for injection

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Naropin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No