Analgesia Clinical Trial
Official title:
Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery that utilizes camera based scopes and specialized instruments through keyhole sized ports to remove lesions in the thoracic cavity. Despite reduced surgical trauma compared to the traditional thoracotomy approach, patients continued to experience moderate to severe postoperative pain. Pain medication such as opioids is commonly utilized for postoperative pain control but is associated with side effects. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery and decrease the risk of pulmonary complication. This study aims to investigate the analgesic effect of ESPB in managing pain following VATS.
Status | Not yet recruiting |
Enrollment | 82 |
Est. completion date | January 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients 2. Scheduled for an elective VATS 3. American Society of Anesthesiologists (ASA) physical status I to III Exclusion Criteria: 1. Age < 18 2. BMI > 40 3. Patient refusal or inability to provide consent 4. Chronic pain conditions 5. Daily opioid use > 60 mg of oral morphine equivalents 6. Cognitive or psychiatric condition that makes it challenge to assess pain 7. Conversion to open thoracotomy 8. Allergy to any of the drugs used in this study 9. Contraindication to nerve blocks such as infection, severe coagulopathy or pre-existing neuropathy 10. Significant systemic cardiac, respiratory, hepatic or renal diseases 11. Postoperative admission to intensive care unit |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Lawson Health Research Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption in IV morphine equivalents | All source of opioid | First postoperative 24 hour | |
Secondary | Opioid consumption in IV morphine equivalents | All source of opioid | Second postoperative 24 hours | |
Secondary | Area under curve of pain score | 0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever) | First postoperative 24 hour | |
Secondary | Area under curve of pain score | 0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever) | Second postoperative 24 hour | |
Secondary | Post-anesthetic recovery length of stay | In minutes | up to 12 hours | |
Secondary | Hospital length of stay | in hours | Up to 1 week | |
Secondary | Incidence of nausea | patient reported sensation of nausea related to opioid intake | Up to 1 week | |
Secondary | Incidence of vomiting | nurse recorded incidence of vomiting related to opioid intake | Up to 1 week | |
Secondary | Incidence of drowsiness | lightheadedness, drowsiness reported by patient related to opioid intake | Up to 1 week | |
Secondary | Incidence of pruritus | new onset of pruritus related to opioid intake | Up to 1 week | |
Secondary | Incidence of infection at block injection site | defined as redness, swelling, tenderness and/or prurulent discharge | Up to 1 week | |
Secondary | Incidence of symptomatic hematoma at block injection site | collection of blood confirmed by ultrasound | Up to 1 week | |
Secondary | Incidence of paresthesia in the area covered by block | paresthesia, decreased sensation thought to related to block | Up to 1 week | |
Secondary | Incidence of hypoxia | hypoxia (SaO2 < 90%) despite > 5 L oxygen | during the first 24 hours | |
Secondary | Incidence of mechanical ventilation | requiring re-intubation | during the first 24 hours | |
Secondary | Incidence of tachypnea | Respiratory rate more than 30 for more than 2 hours | during the first 24 hours |
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