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A clinical trial to study the efficacy of subtenons block for pain relief in children undergoing vitreoretinal surgery under general anaesthesia as compared to intravenous fentanyl alone

Comparison of pain and postoperative nausea vomiting following vitreo-retinal surgery under general anaesthesia with sub-tenons block versus general anaesthesia with intravenous fentanyl in paediatric patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000142
Enrollment
200
Registered
2009-04-08
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: null- Children undergoing vitreo- retinal surgery Health Condition 2: H33- Retinal detachments and breaks

Interventions

Intervention1: sub Tenons block: In this group sub Tenons block was administered in addition to intravenous fentanyl administered during general anaesthesia. Control Intervention1: intravenous fentany

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II children aged 5-15 years undergoing vitreo-retinal surgery will be studied after informed parental consent.

Exclusion criteria

Exclusion criteria: 1. Parents of children unwilling to give consent. 2. Patients on peri-operative steroids. 3. Patients with any contra-indication to administering sub-tenon?s block i.e prior redness, inflammation in the eye. 4. any child undergoing only silicone oil removal surgery ( this is a minor posterior segment surgery.)

Design outcomes

Primary

MeasureTime frame
To assess decrease in pain associated with vitreo-retinal surgery in paediatric age group using an opioid?free technique (sub-tenon?s block) with general anaesthesia as compared to standard general anaesthesia technique using intravenous fentanyl for analgesia.Timepoint: Perioperative surgery i.e during the surgery and the first 24 hrs postoperatively

Secondary

MeasureTime frame
Assess perioperative nausea vomiting, incidence of oculocardiac reflex in children undergoing VR surgeryTimepoint: perioperative and first 24 hours postoperatively

Countries

India

Contacts

Public ContactAnjolie Chhabra

All India Institute of Medical Sciences, Ansari Nagar, New Delhi

anjolie5@hotmail.com911125220616

Outcome results

None listed

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