Mannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery
ISRCTN | ISRCTN36315634 |
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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
Scientific
University Medical Center
Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Phone | +31 (0)30 2506163 |
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m.j.m.m.giezeman@umcutrecht.nl |
Study information
Study design | Randomised double blind active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Does 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) studied | 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 |
Primary outcome measure | 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 study start date | 01/01/2005 |
Completion date | 01/01/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 50 |
Key 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) |
Key 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 |
Date of first enrolment | 01/01/2005 |
Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |