|- candidate number||1783|
|- NTR Number||NTR468|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||24-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Mannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery.|
|- Scientific Title||Mannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery.|
|- hypothesis||Does mannitol, administered intravenously during 48 hours, prevent a recurrence or an exacerbation of complex regional pain syndrome after surgery.|
|- Healt Condition(s) or Problem(s) studied||Complex Regionaal Pain Syndrome (CRPS)|
|- Inclusion criteria||1. Age at least 18 jaar;|
2. History of CRPS, indicated by the presence of the following characteristics during the past 3 years (adapted CRPS I criteria according to Bruehl)
a. Continuing pain, disproportionate to any inciting event;
b. At least 1 symptom in of the following 4 categories:
b1. Sensory: hyperalgesia
b2. Vasomotor: temperature asymmetry or skin color changes or skin color asymmetry;
b3. Sudomotor/edema: edema or sweating changes or sweating asymmetry;
b4. Motor/trophic: diminished range of motion or motor dysfunction or trophic changes;
3. The presence of CRPS signs is not mandatory;
4. Surgery on the affected upper extremity (a.o. carpal-tunnelsyndrome, joint surgery on wrist and fingers).
|- Exclusion criteria||1. Allergy to mannitol;|
2. Allergy to hydrochlorothiazide;
3. Clinically relevant renal impairment (creatinine >= 150% normal);
4. Hystory of cardiac failure (orthopnea, edema, exertional dyspnea, admissions for cardiac failure);
5. CRPS in both upper extremities;
6. Other pain syndromes affecting functional testing or pain scores;
9. No informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2005|
|- planned closingdate||1-jan-2007|
|- Target number of participants||50|
|- Interventions||The treatment group will receive mannitol 10%, 1l daily, via a continuous i.v. infusion, starting at the beginning of anesthesia. In addition, a placebo tablet hydrochlorothiazide is administerde twice daily, starting after surgery.|
The placebo group will receive 1l NaCl 0.9%, also via continuous infusion starting at the beginning of anesthesia. In addition, patients will receive a tablet of 25 mg hydrochlorothiazide twice daily.
Treatment will continue for 48 hours postoperatively.
|- Primary outcome||The Impairment Level Sum Score (ISS) after 3 months, which is a composite score, accounting for pain, edema, temperature and range of motion.|
|- Secondary outcome||1. Disability of Arm, Shoulder and Hand, Dutch Language Version (DASH-DLV) score;|
2. Individual components of ISS;
3. Perioperative VAS-pain scores;
4. Number of medication changes;
5. Side effects.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| M.J.M.M. Giezeman|
|- CONTACT for SCIENTIFIC QUERIES|| M.J.M.M. Giezeman|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Department of Anesthesiology|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU), Department of Anesthesiology|
|- Brief summary||Introduction: Complex Regional Pain Syndrome (CRPS) is a syndrome that may lead to chronic pain and disability of the extremities. Surgery or trauma cause about 75% of cases. A recurrence or exacerbation of complaints may be triggered by surgery, with recurrence rates being reported between 29 and 72%.|
Up till now, no prophylaxis against the recurrence of CRPS after surgery has been studied in a randomized, controlled way. Several interventions have been reported to be effective in retrospective analyses, however.
Mannitol has been proposed for the prevention of a relapse of CRPS after surgery due to its oxygen-radical scavenging properties. In the Netherlands, it is therefore often used perioperatively, though evidence for its effectiveness is lacking and side effects and additional costs are involved.
Aim: This study has been set up to establish whether perioperative administration of mannitol to patients with CRPS can prevent an exacerbation or recurrence of complaints.
Methods: Patients with CRPS in a single arm, undergoing plastic surgery on that arm, will be included. They will be randomized to mannitol or placebo treatment. The intervention consists of administering a 1000 ml/24h i.v. infusion of mannitol 10% or a placebo. To mask the diuretic effects of mannitol, a placebo tablet or 50 mg hydrochlorothiazide are administered, respectively.
Preoperatively and after 3 months follow-up, pain (VAS and McGill Pain Questionnaire, MPQ), volume, temperature and function (Range of Motion, ROM), are measured. These parameters are compounded to the Impairmant-level Sum Score (ISS). Patient’s assesment of (change of) pain and impairment are assessed by the Disability of Arm. Shoulder and Hand questionnaire – Dutch Language Version (DASH-DLV).
Outcomes: Primary outcome is the difference of change of ISS after 3 months between the intervention and treatment group. Secondary outcome parameters include DASH-DLV, perioperative VAS, numer of medication changes and number of side-effects.
|- Main changes (audit trail)|
|- RECORD||24-okt-2005 - 15-nov-2009|