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Completed

NCT Number: NCT02150460

A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria

The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.

This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.

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Key information

Conditions

Anaesthesia Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Eye Centre

Kaduna, Kaduna State, 800001, Nigeria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 years and above
  • Diagnosed with uncomplicated senile cataract
  • Visual acuity of <3/60

Exclusion criteria

  • Impaired mental status
  • Difficulty in speaking
  • Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
  • Previous surgery in the same eye
  • Glaucoma
  • Impaired ocular motility
  • Eyelid abnormalities
  • Patients with only one eye

Treatment and study plan

One-site peribulbar injection

Procedure

injection into the inferior medial orbital compartment

Two- site peribulbar injection

Procedure

Two injections into the infero-temporal and supero-nasal orbital compartments

Primary outcomes

  1. Time Taken to Achieve Adequate Akinesia

    Time frame: 10 minutes and 15 minutes

    Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.

  2. Supplementary Injection(s)

    Time frame: 5 minutes

    After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later

  3. Complications of Local Anaesthetic Injection

    Time frame: 0,10 and 15 minutes

    Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc

    Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc

  4. Pain Score for Local Anaesthetic Injection

    Time frame: 20 minutes

    Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain

  5. Pain Score for Cataract Surgery

    Time frame: 20 minutes

    Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain

Secondary outcomes

  1. Volume of Anaesthetic Drug (ml)

    Time frame: 10 and 15 minutes

    Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery

  2. Total Number of Injections

    Time frame: 15 minutes

    Total number of injections required to achieve an akinesia score of <4

  3. Surgeon Satisfaction Score for Local Anaesthetic Block

    Time frame: 20 minutes

    Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)

  4. Acceptability of the Anaesthetic Block to the Subject

    Time frame: 25 minutes

    Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye

  5. Duration of Cataract Surgery (Minutes)

    Time frame: At the end of surgery

    Time interval from conjunctival incision to application of eye pad

Sponsors and collaborators

Lead sponsor

National Eye Centre, Kaduna

Other Gov

Registry information

Official study title

A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
May 29, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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