Skip to content

To study the effect of Hydroxyethyl-starch in caudal block analgesia in children undergoing surgery below umbilicus

EFFICACY OF HYDROXYETHYL-STARCH WITH BUPIVACAINE IN PROLONGATION OF DURATION OF CAUDAL BLOCKS IN PAEDIATRIC INFRAUMBILICAL SURGERIES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034195
Enrollment
50
Registered
2021-06-11
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: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 2: Q422- Congenital absence, atresia and stenosis of anus with fistula Health Condition 3: Q423- Congenital absence, atresia and stenosis of anus without fistula Health Condition 4: Q420- Congenital absence, atresia and stenosis of rectum with fistula Health Condition 5: Q421- Congenital absence, atresia and stenosis of rectum without fistula Health Condition 6: Q559- Congenital malformation of m

Interventions

Intervention1: Caudal block in Group BH including 25 patients: caudal block with 0.25 percent bupivacaine at a dose of 1mL/Kg using 6% hydroxyethyl starch (130/0.4) with a maximum volume of 20ml. Cont

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2 to 10 years. 2. Undergoing infraumbilical surgeries. 3. ASA I and ASA II category patients. 4. All those parents or legal guardians giving consent

Exclusion criteria

Exclusion criteria: 1. Patient or guardian refusal. 2. Patients with history of coagulation disorder. 3. Infection at the puncture site. 4. Pre-existing neurological disease. 5. Known allergy to the local anaesthetic or hydroxyethyl starch.

Design outcomes

Primary

MeasureTime frame
To study the duration of analgesia from completion of caudal block upto the first requirement of analgesics postoperativelyTimepoint: Patient will be assessed in post anaesthesia care unit at following time intervals for pain - 0 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Analgesia in the form of fentanyl 0.5 mcg/kg will be given on verbal complaint of pain or when FLACC/VAS score of pain is more than 3.

Secondary

MeasureTime frame
Total intraoperative analgesic requirementTimepoint: HR, BP will be recorded every 5 min in intraoperative period. Rescue analgesia as Fentanyl 0.5 mcg/kg will be given if there is more than 20 percent increase in HR or BP for 2 mins or more and will be repeated after 10 min if required.;To study the side effects when HES used in caudal block.Timepoint: Patient will be assessed for any side effects like PONV,Bradycardia, Desaturation, Pruritis, Urinary retention and prolonged motor blockade at 0 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr.;Analgesic requirement in postoperative period upto 6 hoursTimepoint: Patients will be monitored after completion of surgery in the post anaesthesia care unit. Pain will be assessed using FLACC score in patients aged 6 years or less and VAS score in patients aged above 6 years. Fentanyl 0.5 mcg/kg will be given if there is verbal complaint of pain or when FlACC/VAS score is more than 3. The same dose will be repeated in increments until pain is relieved upto a maximum dose of 2mcg/kg per hour.;Duration of motor block measured as time to first spontaneous limb movement.Timepoint: Motor block will be assessed using Bromage score in the recovery room after surgery at 0 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. The time period at which spontaneous limb movement is achieved will be noted in recovery room and duration of motor block will be measured as time from completion of caudal block till time to spontaneous limb movement.

Countries

India

Contacts

Public ContactSuraj Verma

AIIMS NEW DELHI

drgpd@yahoo.com8800317547

Outcome results

None listed

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