Erector Spinae Plane Block versus Caudal Epidural Block for children undergoing lower abdominal surgery
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/04/032717
- Lead Sponsor
- Dr Zainab Ahmad
- Brief Summary
Aim of the study is to compare the effect of Erector Spinae Plane Block with the effect of Caudal Epidural Block in pediatric patients undergoing lower abdominal surgery under general anesthesia. Study will be a single blind randomised study with blinding of outcome assessors and will be conducted in AIIMS Bhopal under the Department of Anesthesiology, and Department of Pediatric Surgery. Both erector spinae plane block and caudal epidural block will be proceeded under the Ultrasound guidance. Primary outcome to be compared will be the duration of post operative analgesia defined as time to first request of rescue analgesia. Randomisation will be done using computer generated random number table and allocation concealment will be done using sequentially numbered opaque sealed envelopes. The study will include all pediatric patient of age 1- 9 years of either sex, ASA(American society of Anesthesiology classification of physical status) grade 1 and 2 undergoing elective and emergency lower abdominal surgeries. Patients having any contraindications to regional technique, any coagulation disorder, local infection around site of block, any anatomical deformity, progressive neurological disorder, any cutaneous anomaly, any hypersensitivity to the local anesthetics or inabilty to identify the landmarks; will be excluded from the study. A standard anesthesia technique will be followed in all the patients included in the study. Well informed written consent will be taken from the patients included in the study. All the records will be confidential, and the patient identity would be known to the chief investigatorand would not be released to anybody else. Participation in the study will be voluntary and refusal to participate will not influence care of the participants in the hospital anyway.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
- The study will include all paediatric patients of age 1 year.
- 9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower abdominal surgery.
- ·Contraindications to regional technique e.g. allergy to local anesthetic drugs, infection around site of block.
- .Any coagulation disorder, sepsis.
- ·Patient having anatomical deformities & progressive neurological disorder, ·Patient with cutaneous anomalies (angioma, hair tuft, naevus, dimple at the site of block) ·Inability to identify landmarks.
- ·Patient on enti-epileptic drugs or any other enzyme inducers.
- ·Hypersensitivity/contra-indication to any of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of post-operative analgesia, defined as time to first request of rescue analgesia ( defined as a FLACC score 4 or verbal request of analgesics from verbal children) at any time from the time of completion of surgery. Patients will be evaluated at 0, 30 minutes, 1 hours, 2 hours, 6 hours, 12 hours and 24 hours after surgery.
- Secondary Outcome Measures
Name Time Method 1. Intraoperative opioid requirement - number of additional doses of Fentanyl administered intraoperatively. 2. Postoperative pain scale - FLACC score
Trial Locations
- Locations (1)
Department of Anesthesiology and Critical Care, and Department of Pediatric Surgery AIIMS Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
Department of Anesthesiology and Critical Care, and Department of Pediatric Surgery AIIMS Bhopal🇮🇳Bhopal, MADHYA PRADESH, IndiaDr Ashutosh PandeyPrincipal investigator8960589413ashu95pandey@gmail.com