Contact information
Type
Scientific
Primary contact
Dr M.J.M.M. Giezeman
ORCID ID
Contact details
University Medical Center
Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2506163
m.j.m.m.giezeman@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Does mannitol, administered intravenously for 48 hours, prevent a recurrence or an exacerbation of complex regional pain syndrome after surgery
Ethics approval
Received from local medical ethics committee
Study design
Randomised double blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Complex Regional Pain Syndrome (CRPS)
Intervention
The treatment group will receive mannitol 10%, 1l daily, via a continuous IV infusion, starting at the beginning of anesthesia. In addition, a placebo tablet hydrochlorothiazide is administered 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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/01/2005
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age at least 18 years
2. History of CRPS, indicated by the presence of the following characteristics during the past 3 years (adapted CRPS I criteria according to Bruehl):
2.1. Continuing pain, disproportionate to any inciting event
2.2. At least 1 symptom in one of the following 4 categories:
2.2.1. Sensory: hyperalgesia
2.2.2. Vasomotor: temperature asymmetry or skin color changes or skin color asymmetry
2.2.3. Sudomotor/edema: edema or sweating changes or sweating asymmetry
2.2.4. 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-tunnel syndrome, joint surgery on wrist and fingers)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Allergy to mannitol
2. Allergy to hydrochlorothiazide
3. Clinically relevant renal impairment (creatinine ≥150% normal)
4. History 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
Recruitment start date
01/01/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center
Utrecht
3508 GA
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Utrecht (UMCU) (Netherlands) - Department of Anesthesiology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary