Comparing the duration of postoperative pain relief with plain ropivacaine(local anesthetic)and adding nalbuphine(opiod) to ropivacaine for caudal epidural block in pediatric infra-umbilical sugeries.

Comparative analysis of postoperative analgesic effect of caudal ropivacaine versus ropivacaine with nalbuphine in infra-umbilical pediatric surgeries: A randomized, double-blinded, Pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053805

Enrollment

Registered

2023-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: N368- Other specified disorders of urethra

Interventions

Intervention1: caudal epidural: 0.2 % ropivacaine ,0.75ml per kg given in caudal epidural and post-operative analgesia observed for 24hours Control Intervention1: caudal epidural: 0.2 ropivacaine 0.7

Eligibility

Inclusion criteria

Inclusion criteria: ASA1 AND 2 , INFRAUMBILICAL SURGERIES, CONSENT

Exclusion criteria

Exclusion criteria: NOT WILLING FOR CONSENT, INFECTION AT INJECTION SITE , PRE OPERATIVE OPIOD CONSUMPTION, PREVIOUS LUMBAR SPINE SURGERY, CONTRAINDICATION TO REGIONAL ANAESTHESIA , HYPERSENSITIVITY TO DRUGS , LUMBO SACRAL ANAMOLY

Design outcomes

Primary

Measure	Time frame
It is the duration required for 1st rescue postoperative analgesia.Timepoint: every hour for 1st 4 hours, 2nd hourly for 8hours followed by 6th hourly for next 12 hours.	—

Secondary

Measure	Time frame
Hemodynamics- heart rate, systolic & diastolic blood pressure & oxygen saturation recorded before the block, every 10 min after caudal block and 15 min after recovery. Pain scale- pain score will be assessed using FLACC scale every hour for 1st 4hours, then 2nd hourly for 8hours and then 4 hourly for next 12hrs. FLACC scale has five criteria: face, legs, activity, cry, consolability, which are each assigned a score of 0,1or 2. The duration of absolute analgesia will be deï¬?ned as the time from caudal injection until pain score is 2. Rescue analgesia will be given if the pain score is 4. Timepoint: 24HRS	—

Measure

Time frame

Hemodynamics- heart rate, systolic & diastolic blood pressure & oxygen saturation recorded before the block, every 10 min after caudal block and 15 min after recovery. Pain scale- pain score will be assessed using FLACC scale every hour for 1st 4hours, then 2nd hourly for 8hours and then 4 hourly for next 12hrs. FLACC scale has five criteria: face, legs, activity, cry, consolability, which are each assigned a score of 0,1or 2. The duration of absolute analgesia will be deï¬?ned as the time from caudal injection until pain score is 2. Rescue analgesia will be given if the pain score is 4. Timepoint: 24HRS

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Countries

India

Contacts

Public ContactG Sai Mahitha

AIL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR

subratsingh@gmail.com7893383449

Outcome results

None listed

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