Comparison of pain relief provided with general anaesthesia and peribulbar block to conventional general anaesthesia in children undergoing enucleation surgery for with retinoblastoma - A randomised double-blind parallel controlled trial.

Comparison of analgesic efficacy of general anaesthesia and peribulbar block to conventional general anaesthesia in children with retinoblastoma undergoing enucleation surgery- A randomised double-blind parallel controlled trial.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/033216

Enrollment

Registered

2021-04-28

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: C692- Malignant neoplasm of retina

Interventions

Intervention1: PB group: Peribulbar block with two injection technique (inferolateral and superonasal) will be administered by the surgeon under all aseptic precautions prior to surgery after child is

Eligibility

Inclusion criteria

Inclusion criteria: Children varying in age from neonates to 10 years of age of ASA physical status grade I & II scheduled to undergo enucleation surgery for retinoblastoma.

Exclusion criteria

Exclusion criteria: 1. Parent/patient refusal 2. Acute or chronic infection of eye 3. Coagulopathy 4. Allergy to local anaesthetics (LA) 5. Extra-ocular or exophytic tumour 6. Intracranial extension

Design outcomes

Primary

Measure	Time frame
The number of children having moderate to severe pain in the first 6 hours post enucleation surgery.Timepoint: From immediately postoperatively to 6 hours following enucleation surgery (0-6 postoperative hours).	—

Secondary

Measure	Time frame
1. Incidence and severity of oculo-cardiac reflex 2. Pain scores 3. Time to first analgesic requirement 4. Incidence of postoperative nausea and vomiting 5. Total number of children with moderate to severe pain in the 6-24 hour period. 6. The total perioperative fentanyl requirement(mcg/kg)intraoperatively and postoperatively. 7. Total 24 hours postoperative ibuprofen requirement (mg/kg). 8. Parental satisfaction. Timepoint: 1 Intraoperatively. 2. 0-2, 2-6, 6-12, 12-24 hours post-surgery. 3.from end of surgery to pain scoreâ?¥4. 4. 0-2, 2-6, 6-12, 12-24 hours postop. 5. In the 6-24 postoperative hours. 6. Intraoperatively and 24 hours postoperatively. 7. 24 hours post surgery. 8. 24 hours postoperatively.	—

Measure

Time frame

1. Incidence and severity of oculo-cardiac reflex 2. Pain scores 3. Time to first analgesic requirement 4. Incidence of postoperative nausea and vomiting 5. Total number of children with moderate to severe pain in the 6-24 hour period. 6. The total perioperative fentanyl requirement(mcg/kg)intraoperatively and postoperatively. 7. Total 24 hours postoperative ibuprofen requirement (mg/kg). 8. Parental satisfaction. Timepoint: 1 Intraoperatively. 2. 0-2, 2-6, 6-12, 12-24 hours post-surgery. 3.from end of surgery to pain scoreâ?¥4. 4. 0-2, 2-6, 6-12, 12-24 hours postop. 5. In the 6-24 postoperative hours. 6. Intraoperatively and 24 hours postoperatively. 7. 24 hours post surgery. 8. 24 hours postoperatively.

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Countries

India

Contacts

Public ContactDr Shraddha Dewangan

All India Institute of Medical Sciences

anjolie5@hotmail.com01126593974

Outcome results

None listed

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