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

Introduction: Complex Regional Pain Syndrome (CRPS) is a syndrome that may lead to chronic pain and disability of the extremities. Surgery or trauma cause about 75% of cases. A recurrence or exacerbation of complaints may be triggered by surgery, with recurrence rates being reported between 29 and 72%.

Up till now, no prophylaxis against the recurrence of CRPS after surgery has been studied in a randomized, controlled way. Several interventions have been reported to be effective in retrospective analyses, however.

Mannitol has been proposed for the prevention of a relapse of CRPS after surgery due to its oxygen-radical scavenging properties. In the Netherlands, it is therefore often used perioperatively, though evidence for its effectiveness is lacking and side effects and additional costs are involved.
Aim: This study has been set up to establish whether perioperative administration of mannitol to patients with CRPS can prevent an exacerbation or recurrence of complaints.


Methods: Patients with CRPS in a single arm, undergoing plastic surgery on that arm, will be included. They will be randomized to mannitol or placebo treatment. The intervention consists of administering a 1000 ml/24h i.v. infusion of mannitol 10% or a placebo. To mask the diuretic effects of mannitol, a placebo tablet or 50 mg hydrochlorothiazide are administered, respectively.
Preoperatively and after 3 months follow-up, pain (VAS and McGill Pain Questionnaire, MPQ), volume, temperature and function (Range of Motion, ROM), are measured. These parameters are compounded to the Impairmant-level Sum Score (ISS). Patient’s assesment of (change of) pain and impairment are assessed by the Disability of Arm. Shoulder and Hand questionnaire – Dutch Language Version (DASH-DLV).


Outcomes: Primary outcome is the difference of change of ISS after 3 months between the intervention and treatment group. Secondary outcome parameters include DASH-DLV, perioperative VAS, numer of medication changes and number of side-effects.

Does mannitol, administered intravenously during 48 hours, prevent a recurrence or an exacerbation of complex regional pain syndrome after surgery.

N/A

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 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.