Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes