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van CCT (UK)

van CCT (UK)

Mannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery.

- candidate number1783
- NTR NumberNTR468
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR24-okt-2005
- Secondary IDsN/A 
- Public TitleMannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery.
- Scientific TitleMannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery.
- hypothesisDoes 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) studiedComplex Regionaal Pain Syndrome (CRPS)
- Inclusion criteria1. 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 criteria1. 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;
7. Infection;
8. Pregnancy;
9. No informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate1-jan-2007
- Target number of participants50
- InterventionsThe 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 outcomeThe Impairment Level Sum Score (ISS) after 3 months, which is a composite score, accounting for pain, edema, temperature and range of motion.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Anesthesiology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Department of Anesthesiology
- PublicationsN/A
- Brief summaryIntroduction: 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)
- RECORD24-okt-2005 - 15-nov-2009

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