Two versus one injection for eye block
| ISRCTN | ISRCTN73431052 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73431052 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/09/2008
- Registration date
- 31/10/2008
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jawad Mustafa
Scientific
Scientific
South Infirmary Hospital
Cork
-
Ireland
Study information
| Study design | Single blinded, prospective, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficacy of Sub-Tenon's block using an equal volume of local anaesthestic administered either as a single or as divided doses |
| Study acronym | SubTenon |
| Study objectives | Our hypothesis was that a divided injection into the Sub-Tenons space would achieve greater, more consistent and more rapid motor blockade then a single injection using equal volumes and mixtures of local anaesthetic solution. |
| Ethics approval(s) | Ethics Committee of Cork University Hospital, approval received in 2003. |
| Health condition(s) or problem(s) studied | Cataract surgery |
| Intervention | On arrival in the induction room, intravenous excess was secured and monitoring with non-invasive blood pressure (NIBP), electrocardiogram (ECG), and pulse oximetry (Datex AS3) established. Topical anaesthesia was established by instillation of benoximate eye drops and after 2 minutes an eye speculum inserted. With the eye in neutral position, the conjunctiva was lifted in the infranasal quadrant with the help of Moorsfields forceps and using Westcott's scissors a small incision was made in the conjunctiva. A 19 gauge Stephens's cannula was carefully placed subconjuctivally into the Sub-Tenon's space. In group 1, 5 ml of local anaesthetic solution comprising 2.5 ml of 2% lignocaine with 1:200,000 adrenaline, 15 IU/ml of hyaluronidase and 2.5 ml of 0.5% bupivacaine was injected over thirty seconds. After the injection orbital pressure was applied for two minutes. In group 2, 3 ml of the same anaesthetic solution described above was injected and cannula withdrawn followed by application of orbital pressure for 2 minutes. A further 2 ml of the same anaesthetic solution was injected through the same conjunctival incision with approx three minutes between the two injections. Intraocular pressures were measured by a hand held tonometer (knowa) prior to injection and six minutes after the first (or sole) injection and compared with pre-injection value. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Benoximate, lignocaine, adrenaline, hyaluronidase, bupivacaine |
| Primary outcome measure | Measurement of movement was performed by the operating surgeon who was unaware of the anaesthetic technique used in all four quadrants (inferior, superior, redial, lateral) using a vernier calliper and scored according to movement: 0 = no movement 1 = movement of less than 2 mm 2 = movement of more than 2 mm Motor function was evaluated at two time intervals, 3 and 6 minutes after the initial injection. Overall movement score was obtained by combining the scores of these four muscles. This score ranged from 0 (no movement) to 8 (complete movement) and was categorised into two groups, akinesia (score 0 - 4) and no akinesia (score 5 - 8). All measured during the surgery. |
| Secondary outcome measures | Chemosis and subconjuctival haemorrhage were also assessed by surgeons before starting surgery as mild, moderate or severe. All measured during the surgery. |
| Overall study start date | 01/06/2003 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. American Society of Anaesthesiologists (ASA) I - III patients undergoing cataract surgery 2. No age range, both male and female patients |
| Key exclusion criteria | 1. Allergy to any of the drugs administered 2. Impaired mental status 3. Uncontrolled glaucoma 4. Clotting abnormalities 5. Recent surgical procedure on the same eye |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Ireland
Study participating centre
South Infirmary Hospital
Cork
-
Ireland
-
Ireland
Sponsor information
Cork University Hospital (Ireland)
University/education
University/education
Wilton
Cork
-
Ireland
"ROR" |
https://ror.org/04q107642 |
|---|
Funders
Funder type
Other
Investigator initiated study - no extra funding required as Sub-Tenon's block is routinely used
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/03/2009 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
