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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25885

Enrollment

Registered

2005-10-24

Start date

2005-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome

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 twic

Eligibility

Inclusion criteria

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

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; 7. Infection; 8. Pregnancy; 9. No informed consent.

Design outcomes

Primary

Measure	Time frame
The Impairment Level Sum Score (ISS) after 3 months, which is a composite score, accounting for pain, edema, temperature and range of motion.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactM.J.M.M. Giezeman

University Medical Center Utrecht (UMCU), Department of Anesthesiology, P.O. Box 85500

m.j.m.m.giezeman@umcutrecht.nl+31 (0)30 2506163

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)