Comparison of Analgesic Efficacy of Ultrasound Guided Retrolaminar Block vs Caudal Block for Paediatric Patients Undergoing Open Inguinal Surgeries: A Non-Inferiority Randomised Controlled Trial
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- All India Institute of Medical Sciences, Patna
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Time to first rescue analgesia
Overview
Brief Summary
Regional anaesthesia for inguinal surgeries in children has attracted increasing interest and different technique like like subarachnoid,caudal,epidural block,wound infiltration,ilioinguinal and paravertebral block have been used with varying success.
In Paediatric surgery caudal block is a low cost,simple and effective procedure for post operative analgesia.
Retrolaminar Block is one of the newer and simpler alternative technique to the traditional caudal block.Drug is deposited into the retrolaminar spacebetween the lamina of T12 and paraspinal muscle.
Caudal block is most common regional anaesthesia technique used for inguinal surgeries in paediatric patients. Caudal block is not free of complications and can include side effects and complications like hypotension,motor blockage,urinary retension,subdural,intravascular or intraosseus injections of the drug,injury to nerve roots and spinal cord infections etc.Retrolaminar block in other hand is less invasive and the target is away from neuroaxis,rendering it potentially safe.
Through this study,we are trying to explorean alternative regional anaesthesia technique that is less invasive with non-inferior analgesic benefit compared to Caudal block.
No RCT has been conducted till date comparing Retrolaminar Block to Caudal block in paediatric patients.
We expect that Retrolaminar Block will provide analgesia non inferior to Caudal block in Paediatric patients undergoing inguinal surgeries.This will help us to inculcate this block as routine practice in our setup in this subset of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 6.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 1-6years ASA I and II patients scheduled for inguinal surgeries.
Exclusion Criteria
- •Patients with coagulation disorders Patients hypertensive to study medications Patients with developmental or mental delay Skin lesions or infection at the planned site of needle insertion Congenital vertebral anomalies.
Outcomes
Primary Outcomes
Time to first rescue analgesia
Time Frame: assessment within 24 hours post surgery estimated at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours.
Secondary Outcomes
- Intraoperative fentanyl use(Number of patients requiring rescue analgesia in 24hours/till the time of discharge)
Investigators
Dr Suman Das
AIIMS Patna