Evaluation and comparison between 0.125% vs 0.25% bupivacaine for ultrasound guided sacral erector spinae block in paediatric patients undergoing hypospadias repair.
- Conditions
- Hypospadias, unspecified, (2) ICD-10 Condition: N488||Other specified disorders of penis, (3) ICD-10 Condition: N488||Other specified disorders of penis,
- Registration Number
- CTRI/2023/03/050226
- Lead Sponsor
- Pt. B.D. Sharma PGIMS Rohtak
- Brief Summary
Paediatric male patients aged 8 to 12 yrs with American Society ofAnesthesiologists (ASA) physical status I or II scheduled to undergo surgery for hypospadiasrepair will be included in the study. All children will be evaluated one day prior to surgery. The patients will be instructed on usage of a10mm visual analog scale (VAS) for pain [graded from 0 ( no pain) to 10 ( most severe pain)during preoperative evaluation .From computer generated randomization, patients will be randomly allocated to one of the two groups comprising of thirty patients. Inhalational induction of anaesthesia will be done in a standardized manner to facilitate the placement of supraglottic airway device. Group I (n=30) will be given ultrasound guided sacral erector spinae plane blockwith 1 mlkg-1of 0.125% bupivacaine.2. Group II(n=30) will be given ultrasound guided sacral erector spinae plane blockwith 1 mlkg-1of 0.25% bupivacaine .Pain assessment will be done postoperatively using VAS score at 0 hr, every 15 mins upto 1hr, every half an hour upto 2 hours, 2 hrly upto 12 hours and then at 18th hour and 24th hourpostoperatively. Rescue analgesic will be given at VAS score≥ 4. Patient will be given 15mgkg-1paracetamolinfusion over 10 min but not more frequently than 6 hours. If pain persists after paracetamoladministration, oral ibuprofen 10mgkg-1 will be given but not more frequently than 8 hrs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 60
Paediatric male patients aged 8 to 12 yrs with American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo surgery for hypospadias repair will be included in the study.
Patients with history of developmental delay, allergic reactions to local anaesthetic infection at the needle insertion site bleeding disorders and on anticoagulants parental refusal shall not be included in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time for requirement of first rescue analgesic Pain assessment will be done postoperatively using VAS score at 0 hr, every 15 mins upto 1 | hr, every half an hour upto 2 hours, 2 hrly upto 12 hours and then at 18th hour and 24 | th hour | postoperatively.
- Secondary Outcome Measures
Name Time Method 1) Total intraoperative fentanyl consumption 2) Post-operative pain score
Trial Locations
- Locations (1)
Pt.B.D. Sharma PGIMS ,Rohtak
🇮🇳Rohtak, HARYANA, India
Pt.B.D. Sharma PGIMS ,Rohtak🇮🇳Rohtak, HARYANA, IndiaDr Bharti SinglaPrincipal investigator9009369698drbhartibs@gmail.com