An interventional study of Erector spinae plane block and Sham block in Hysterectomy, Cystectomy and Regional Anesthesia, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
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
Ropivacaine 0.5% 20 mL at each site of ESPB
Skin infiltration only
Opioid consumption
Postoperative opioid consumption in oral morphine equivalents
Time frame: First 12 postoperative hour
Pain score
Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours
Time frame: First 12 postoperative hour
Length of stay in post-anesthetic recovery unit
Length of stay in post-anesthetic recovery unit
Time frame: until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively
Length of stay in hospital
Length of stay in hospital
Time frame: until discharge from hospital, up to 7 days postoperatively
Number of participants with opioid related complication
Nausea, vomiting, pruritus
Time frame: Until discharge, up to 7 days postoperatively
Number of participants with block related complication
Hematoma, nerve deficit, pneumothorax
Time frame: Until discharge, up to 7 days postoperatively
Pain score 12 - 24 hour
Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour
Time frame: 12th to 24th postoperative hour
Opioid consumption 12 - 24 hour
Postoperative opioid consumption in oral morphine equivalents
Time frame: 12th to 24th postoperative hour
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's