Clonidine as an adjuvant in retrobulbar block reduces post-operative pain and use of analgesics.
ID
Bron
Verkorte titel
Aandoening
Anaesthesia for patients scheduled for retinal cryocoagulation and episcleral explant, or cryocoagulation of ciliary body.
Ondersteuning
Postbus 70030
3000 LM, Rotterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Maximal pain level (VAS-score);<br>
2. Time of maximal post-operative pain;<br>
3. Amount of escape medication used;<br>
4. Time of use.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Clonidine as an adjuvant in retrobulbar block reduces post-operative pain and use of analgesics.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Rotterdam Ophthalmic Institute
PO Box 70030
M. Górniak
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
m.gorniak@oogziekenhuis.nl
Wetenschappers
Rotterdam Ophthalmic Institute
PO Box 70030
M. Górniak
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
m.gorniak@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ≥ 18 years;
2. Informed consent;
3. Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant;
4. Glaucoma requiring cryocoagulation of the ciliary body.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2690 |
NTR-old | NTR2820 |
Ander register | Oogziekenhuis Rotterdam / CCMO : OZR-2010-17 / NL34843.078.10; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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