Comparison of effect of a drug with the same drug with one more additional drug administered through Caudal route for comparison of extent of pain relief in children undergoing lower abdominal surgery

Not yet recruiting

• Conditions: Diseases of appendix, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities,

• Registration Number: CTRI/2020/08/026971
• Lead Sponsor: Government institute

Brief Summary

Caudal injections of bupivacaine arecommonly used in children undergoing lower abdominal and urogenital surgery toprovide intraoperative analgesia. There is paucity of literature regarding useof bupivacaine with morphine in caudal analgesia for post-operative analgesia.This study has not been done earlier in our institute. Hence we plan to compareefficacy and possible side effects of bupivacaine versus mixture of bupivacaineand morphine when used in caudal analgesia for post-operative analgesia. A prospective,randomized controlled study will be conducted on patient with ASAI/II physical Status undergoing lower abdominal surgeries undergeneral anaesthesia  after obtaining approval from the hospital ethicscommittee. Prior written informed consent will be taken from parents of all thepatients in the language they understand. Total number of patients 100will be enrolled and divided into two group: GROUP –I (n = 50) will bereceiving Caudal analgesia with bupivacaine 0.25% (1 ml kg-1)GROUP-II (n = 50) will be receiving Caudal analgesia with bupivacaine 0.25% (1ml kg-1 ) and morphine 40 mcg kg-1. Pain assessment will be doneusing  FLACC score which will be recorded at 0, 4, 8, 12 and 24 hrs aftersurgery by the observer. Rescue analgesia will be givenfor FLACC score ≥ 4 in the form of Inj. Paracetamol 15 mg kg-1 intravenous. The study will be a double blind randomly allocated design. Local or systemiccomplications throughout the study will be recorded and managed accordingly. There is noconflict of interest.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-08
• Study Start: 2020-08-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.American Society of Anaesthesiology I and II physical status undergoing Lower Abdominal Surgeries.

Exclusion Criteria

• Allergic to study drugs 2.
• Cardiac, pulmonary,neurological and musculoskeletal diseases 3.
• Bleeding diathesis 4.
• Skin infection on back 5.
• Congenital anomalies of lower back 6.
• Patients requiring intra-operative analgesia in form of opioids 7.
• History of mental retardation and delayed milestones that may interfere with pain assessment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of caudal analgesia post operatively in paediatric patients aged 1-5 years undergoing lower abdominal surgery	0,4,8,12,24 hours

Secondary Outcome Measures

Name	Time	Method
To study complications pertaining to caudal analgesia with bupivacaine and bupivacaine with morphine for post-operative analgesia in paediatric patients.	0,4,8,12,24 hours

Trial Locations

Locations (1)

Command Hospital , Western Command , Chandimandir; 🇮🇳 Panchkula, HARYANA, India

Command Hospital , Western Command , Chandimandir

🇮🇳Panchkula, HARYANA, India

Dr Mayank Dhiman

Principal investigator

7018021052

mustang8055@gmail.com