To compare effects of ropivacaine alone and ropivacaine along with nalbuphine and magnesium sulphate in pain control among children in regional anaesthesia(caudal block)

A comparative evaluation of analgesic efficacy of nalbuphine and magnesium sulphate as an adjuvant to ropivacaine in paediatric caudal block

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037040

Enrollment

Registered

2021-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: U07-U07- Provisional assignment of new diseases of uncertain etiology or emergency use

Interventions

Intervention1: Ropivacaine: Patients will receive 1ml/kg of 0.2% Ropivacaine with 1ml normal saline in paediatric caudal block. Control Intervention1: Nalbuphine as adjuvant to Ropivacaine.: Patient w

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric participants aged between 1-10 years. American Society of Anaesthesiologists grade I and II patients. Patients undergoing infraumbilical surgeries.

Exclusion criteria

Exclusion criteria: History of developmental delay or mental retardation, which could make observational pain intensity assessment difficult. Children with known allergy to any of the study drugs. Children with coagulation disorders. Childrenwith coexisting medical illness. Pre-existing neurological diseases. Anatomical abnormalities of spine and sacrum. Any signs of infection at the site of the proposed caudal block.

Design outcomes

Primary

Measure	Time frame
To evaluate analgesic efficacy of ropivacaine alone in paediatric caudal block To evaluate analgesic efficacy of ropivacaine with nalbuphine in paediatric caudal block To evaluate analgesic efficacy of ropivacaine with magnesium sulphate in paediatric caudal block To compare analgesic efficacy of ropivacaine alone ,with nalbuphine and with magnesium sulphate in paediatric caudal block Timepoint: Duration of analgesia will be assessed. Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.	—

Measure

Time frame

To evaluate analgesic efficacy of ropivacaine alone in paediatric caudal block To evaluate analgesic efficacy of ropivacaine with nalbuphine in paediatric caudal block To evaluate analgesic efficacy of ropivacaine with magnesium sulphate in paediatric caudal block To compare analgesic efficacy of ropivacaine alone ,with nalbuphine and with magnesium sulphate in paediatric caudal block Timepoint: Duration of analgesia will be assessed. Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.

—

Secondary

Measure	Time frame
Monitoring of hemodynamic parameters ( HR,Oxygen saturation ,Temperature) intraoperatively and postoperatively. Perioperative adverse effects will be recorded. Timepoint: Vitals monitoring will be done before induction and every 5 min for half an hour and every 10 min until the end of surgery Postoperative hemodynamic monitoring for 24hrs will be done	—

Countries

India

Contacts

Public ContactDrAmanjot Singh

Guru Gobind Singh Medical College and Hospital.

amanjotrajpal@gmail.com9814921142

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026