Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

NCT ID: NCT03500744

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-08-01

Brief Summary

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.

Conditions

Hysterectomy; Cystectomy; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector spinae plane block

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.

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: PROCEDURE

Ropivacaine 0.5% 20 mL at each site of ESPB

Shame block

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.

Group Type: SHAM_COMPARATOR

Sham block

Intervention Type: PROCEDURE

Skin infiltration only

Interventions

Erector spinae plane block

Ropivacaine 0.5% 20 mL at each site of ESPB

Intervention Type: PROCEDURE

Sham block

Skin infiltration only

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Kamal Kumar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng Lin

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Cheng Lin

London, Ontario, Canada

Countries

Canada

Other Identifiers

111510

Identifier Type: -

Identifier Source: org_study_id