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Clonidine als toevoeging voor de verlenging van pijnbestrijding bij oogoperaties.

- candidate number9263
- NTR NumberNTR2820
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2011
- Secondary IDsOZR-2010-17 / NL34843.078.10; Oogziekenhuis Rotterdam / CCMO
- Public TitleClonidine als toevoeging voor de verlenging van pijnbestrijding bij oogoperaties.
- Scientific TitleClonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, double-blind trial.
- hypothesisClonidine as an adjuvant in retrobulbar block reduces post-operative pain and use of analgesics.
- Healt Condition(s) or Problem(s) studiedAnesthesia, Retinal cryocoagulation, Episcleral explant
- Inclusion criteria1. Age ≥ 18 years;
2. Informed consent;
3. Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant;
4. Glaucoma requiring cryocoagulation of the ciliary body.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate30-apr-2013
- Target number of participants108
- InterventionsThe 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 outcome1. Maximal pain level (VAS-score);
2. Time of maximal post-operative pain;
3. Amount of escape medication used;
4. Time of use.
- Secondary outcome1. 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.
- TimepointsPrimary 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 siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsGórniak 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 summaryRationale:
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)
- RECORD24-mrt-2011 - 11-sep-2014

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