Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Lawson Health Research Institute

Status: Terminated

Conditions: Cystectomy; Hysterectomy; Regional Anesthesia

Treatments: Procedure: Erector spinae plane block; Procedure: Sham block

Study type: Interventional

Funder types: Other

Identifiers

NCT03500744

111510

Details and patient eligibility

About

Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.

Exclusion criteria

1. BMI > 40
2. Non-English speaking
3. Patient refusal or inability to consent
4. Cognitive or psychiatric history that would make it difficult to assess pain score
5. Pre-existing chronic pain condition
6. Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
7. Infection over site of block placement
8. Allergy or contraindication to any study medication
9. Coagulopathy or thrombocytopenia
10. Postoperative ICU admission
11. Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Erector spinae plane block

Experimental group

Description:

The ESPB will be performed with ultrasound guidance. After identifying a suitable location between 8th and 10th thoracic spine transverse process, the overlying skin will be infiltrated with local anesthetic. A 22 gauge 90-mm needle will be inserted to make contact with the transverse process and withdraw slightly. Ropivacaine 0.5% 20 mL will be injected at this location. The same procedure will be performed on the other side. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids.

Treatment:

Procedure: Erector spinae plane block

Shame block

Sham Comparator group

Description:

A sham block will be performed by performing ultrasound examination of the back looking for intended location for ESPB placement. Skin will be infiltrated with local anesthetics but ESPB will not be performed. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids.

Treatment:

Procedure: Sham block