A randomized controlled study of Ultrasound guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair at SMS Medical College, Jaipur.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sawai Man Singh Medical College and attached hospitals, Jaipur
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- To assess postoperative analgesic (Paracetamol) consumption (in mgs) over 24 hours.
Overview
Brief Summary
This randomzied controlled study is being conducted at SMS Medical College and attached Hospitals, Jaipur to evaluate efficacy of Ultrasound guided novel sacral erector spinae block for post operative analgesia in pediatric patients undergoing hypospadias repair . A total of 66 patients will be enrolled and randomized into two groups (Group A with block and Group B with no block). Parameters such as postoperative analgesic consumption, time to first rescue analgesic and pain assessment using FLACC score will be recorded at predefined time intervals. The aim is to assess whether Ultrasound guided novel sacral erector spinae block provide adequate postoperative analgesia, thereby supporting safer anesthetic practices of pain management in hypospadias repair surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients scheduled for elective hypospadias repair surgery.
- •Guardian willing to give informed written consent.
- •Patient of male sex with age group more than 2 years.
- •4.American Society of Anesthesiologists (ASA) physical status I-II.
Exclusion Criteria
- •Patient should not be part of any other study.
- •Patient allergic to any drug given during procedure.
- •Patient with local site infection.
Outcomes
Primary Outcomes
To assess postoperative analgesic (Paracetamol) consumption (in mgs) over 24 hours.
Time Frame: 0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.
Secondary Outcomes
- 1.To assess time to first rescue analgesic.
- 2.To assess postoperative pain using FLACC score.(0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.)
- 3. To assess side effects associated with block.(0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.)
Investigators
Dr Varsha Kothari
SMS Medical College