Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03500744
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy; Cystectomy; Regional Anesthesia	Procedure: Erector spinae plane block; Procedure: Sham block	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Sham block will be performed
• Primary Purpose: Treatment
• Official Title: Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
• Actual Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Erector spinae plane block; Ropivacaine 0.5% 20 mL at each site of ESPB
Sham Comparator: 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.	Procedure: Sham block; Skin infiltration only

Outcome Measures

Primary Outcome Measures

1. Opioid consumption [First 12 postoperative hour]

   Postoperative opioid consumption in oral morphine equivalents

2. Pain score [First 12 postoperative hour]

   Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours

Secondary Outcome Measures

1. Length of stay in post-anesthetic recovery unit [until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively]

   Length of stay in post-anesthetic recovery unit

2. Length of stay in hospital [until discharge from hospital, up to 7 days postoperatively]

   Length of stay in hospital

3. Number of participants with opioid related complication [Until discharge, up to 7 days postoperatively]

   Nausea, vomiting, pruritus

4. Number of participants with block related complication [Until discharge, up to 7 days postoperatively]

   Hematoma, nerve deficit, pneumothorax

5. Pain score 12 - 24 hour [12th to 24th postoperative hour]

   Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour

6. Opioid consumption 12 - 24 hour [12th to 24th postoperative hour]

   Postoperative opioid consumption in oral morphine equivalents

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheng Lin	London	Ontario	Canada	n6c6a7

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

• Principal Investigator: Cheng Lin, Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamal Kumar, Assistant Professor, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT03500744
• Other Study ID Numbers: 111510
• First Posted: Apr 18, 2018
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Sep 2, 2020