Cystectomy, Hysterectomy, Regional Anesthesia
Conditions
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.
Interventions
PROCEDUREErector spinae plane block
Ropivacaine 0.5% 20 mL at each site of ESPB
PROCEDURESham block
Skin infiltration only
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Sham block will be performed
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | First 12 postoperative hour | Postoperative opioid consumption in oral morphine equivalents |
| Pain score | First 12 postoperative hour | Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with opioid related complication | Until discharge, up to 7 days postoperatively | Nausea, vomiting, pruritus |
| Number of participants with block related complication | Until discharge, up to 7 days postoperatively | Hematoma, nerve deficit, pneumothorax |
| 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 |
| Opioid consumption 12 - 24 hour | 12th to 24th postoperative hour | Postoperative opioid consumption in oral morphine equivalents |
| 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 |
| Length of stay in hospital | until discharge from hospital, up to 7 days postoperatively | Length of stay in hospital |
Countries
Canada
Outcome results
None listed