Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Hysterectomy Clinical Trial

Official title:

Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03500744
• Other study ID #: 111510
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystectomy
• Hysterectomy
• Regional Anesthesia

Intervention

Procedure:
• Erector spinae plane block
Ropivacaine 0.5% 20 mL at each site of ESPB
• Sham block
Skin infiltration only

Locations

Country	Name	City	State
Canada	Cheng Lin	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Postoperative opioid consumption in oral morphine equivalents	First 12 postoperative hour
Primary	Pain score	Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours	First 12 postoperative hour
Secondary	Length of stay in post-anesthetic recovery unit	Length of stay in post-anesthetic recovery unit	until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively
Secondary	Length of stay in hospital	Length of stay in hospital	until discharge from hospital, up to 7 days postoperatively
Secondary	Number of participants with opioid related complication	Nausea, vomiting, pruritus	Until discharge, up to 7 days postoperatively
Secondary	Number of participants with block related complication	Hematoma, nerve deficit, pneumothorax	Until discharge, up to 7 days postoperatively
Secondary	Pain score 12 - 24 hour	Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour	12th to 24th postoperative hour
Secondary	Opioid consumption 12 - 24 hour	Postoperative opioid consumption in oral morphine equivalents	12th to 24th postoperative hour