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

ISRCTN ISRCTN36315634
DOI https://doi.org/10.1186/ISRCTN36315634
Secondary identifying numbers N/A
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
08/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.J.M.M. Giezeman
Scientific

University Medical Center
Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

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

Study information

Study designRandomised double blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes mannitol, administered intravenously for 48 hours, prevent a recurrence or an exacerbation of complex regional pain syndrome after surgery
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedComplex Regional Pain Syndrome (CRPS)
InterventionThe 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 typeOther
Primary outcome measureThe Impairment Level Sum Score (ISS) after 3 months, which is a composite score, accounting for pain, edema, temperature and range of motion.
Secondary outcome measures1. 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 study start date01/01/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/01/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center
Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre

Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

ROR logo "ROR" https://ror.org/04pp8hn57

Funders

Funder type

Hospital/treatment centre

University Medical Centre Utrecht (UMCU) (Netherlands) - Department of Anesthesiology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan