No registrations found.
ID
Source
Brief title
Health condition
Anaesthesia for patients scheduled for retinal cryocoagulation and episcleral explant, or cryocoagulation of ciliary body.
Sponsors and support
Postbus 70030
3000 LM, Rotterdam
Intervention
Outcome measures
Primary outcome
1. Maximal pain level (VAS-score);
2. Time of maximal post-operative pain;
3. Amount of escape medication used;
4. Time of use.
Secondary outcome
1. Pharmacokinetics of clonidine will be investigated in 4 men and 4 women;
2. Serum level of clonidine (LC-MS/MS) at 30, 60, 90 and 240 minutes after retrobulbar injection, and at postoperative day. Detection limit will be at least 0.1 µg/l.
Background summary
Rationale:
Clonidine, as an adjuvant in neuraxial local anaesthesia, is generally recognized to prolong motor block and analgesia. It is conjectured to have a similar effect on peripheral nerves and, thus, might help to reduce post-operative pain and use of analgesics.
Objective:
To determine the beneficial effect of a single dose of 150 µg clonidine as an adjuvant to chirocaine in retrobulbar block.
Study design: Randomized, controlled, double-blind trial.
Study population: Patients with indication for retinal cryocoagulation and episcleral explant, or cryocoagulation of ciliary body.
Intervention:
Retrobulbar injection of 150 µg clonidine.
Main study parameters:
Maximal pain level, time of maximal post-operative pain, amount of escape medication used, time of use.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participants receiving clonidine (group 2) may benefit from reduced pain. Burden of participants is negligible and study-related extra time is about 10 minutes. We anticipate the risk of side effects of retrobulbar administration of clonidine to be limited.
Study objective
Clonidine as an adjuvant in retrobulbar block reduces post-operative pain and use of analgesics.
Study design
Primary parameters: 2 and 5 hours postop, bedtime at day of surgery, postop day 1.
Secondary parameters: 30, 60, 90 and 240 minutes after retrobulbar injection, and at postoperative day.
Intervention
The investigational product of this study is clonidine, which will be used as an adjuvant in retrobulbar block. The efficacy of clonidine will be compared with a control group.
Group 1: Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml;
Group 2: Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.
Rotterdam Ophthalmic Institute
PO Box 70030
M. Górniak
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
m.gorniak@oogziekenhuis.nl
Rotterdam Ophthalmic Institute
PO Box 70030
M. Górniak
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
m.gorniak@oogziekenhuis.nl
Inclusion criteria
1. Age ≥ 18 years;
2. Informed consent;
3. Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant;
4. Glaucoma requiring cryocoagulation of the ciliary body.
Exclusion criteria
1. Hypersensitivity to clonidine or any other ingredients in the product;
2. Severe bradyarrhythmia as a result of sick sinus syndrome or 2nd or 3rd degree AV block;
3. Use of oral clonidine;
4. Lapp lactase deficiency or glucose-galactose malabsorption;
5. Bipolar disorder;
6. History of renal insufficiency.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2690 |
NTR-old | NTR2820 |
Other | Oogziekenhuis Rotterdam / CCMO : OZR-2010-17 / NL34843.078.10; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Clonidine as an adjuvant to prolong local analgesia in conventional scleral buckle surgery.
J Ocul Pharmacol Ther. 2014; Sep 4 [Epub ahead of print].
PubMed PMID: 25188774