Comparison of efficacy of ultrasound- guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery: a double blind randomised controlled trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Monika Yadav
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The time to request the first post-operative rescue analgesic dose
Overview
Brief Summary
This study is a randomized, double blind, parallel group, single-centre trial comparing the efficacy of ultrasound-guided erector spinae plane block versus local wound infiltration for post-operative analgesia in patients undergoing video-assisted thoracoscopic surgery in 110 patients in a tertiary care centre in India. The primary outcome measure will be to determine the time to request the first post-operative rescue analgesic dose. The secondary outcomes will be total post-operative rescue analgesic requirement, comparison of quality of recovery, incidence of nausea and vomiting in the first 24 hours post-operatively and numerical rating score at rest and during coughing, comparison of sedation scores at 6, 12, and 24 hours post-operatively
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Informed and written consent ASA physical status 1 and 2 Elective video-assisted thoracoscopic surgery.
Exclusion Criteria
- •Patient refusal Infection at the site Chronic pain patients or patients with analgesic dependence INR more than 1.5 Difficulty in understanding or non-compliance with the quality of recovery questionnaire.
Outcomes
Primary Outcomes
The time to request the first post-operative rescue analgesic dose
Time Frame: The time point at which the patient requests the first post-operative rescue analgesic dose in first 24 hours.
Secondary Outcomes
- Total post-operative rescue analgesic requirement(24 Hours post-operatively)
- Numerical rating score at rest and during coughing(6 ,12 and 24 Hours post-operatively)
- Comparison of quality of recovery(24 Hours post-operatively)
- Comparison of sedation scores(6,12, and 24 Hours post-operatively)
- Incidence of nausea and vomitting(Post-operative period for 24 Hours)
Investigators
Monika Yadav
Medanta -The Medicity