|- candidate number||9263|
|- NTR Number||NTR2820|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2011|
|- Secondary IDs||OZR-2010-17 / NL34843.078.10; Oogziekenhuis Rotterdam / CCMO|
|- Public Title||Clonidine als toevoeging voor de verlenging van pijnbestrijding bij oogoperaties.|
|- Scientific Title||Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, double-blind trial.
|- hypothesis||Clonidine as an adjuvant in retrobulbar block reduces post-operative pain and use of analgesics.|
|- Healt Condition(s) or Problem(s) studied||Anesthesia, Retinal cryocoagulation, Episcleral explant|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2011|
|- planned closingdate||30-apr-2013|
|- Target number of participants||108|
|- Interventions||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.
|- 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.
|- Timepoints||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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Górniak|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Górniak|
|- Sponsor/Initiator ||Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek het Oogziekenhuis|
|- Publications||Górniak M, Proost JH, Veckeneer M, Mulder VC, Wubbels RJ.
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|
|- Brief 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.
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.
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.
|- Main changes (audit trail)|
|- RECORD||24-mrt-2011 - 11-sep-2014|