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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03500744
Other study ID # 111510
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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