Block Duration After Spinal Block and iv Dexamethasone.

Eric Albrecht

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Lower Limb Injury

Treatments: Drug: Dexamethasone; Drug: NaCl 0.0308 MEQ/ML Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03527576

CER 2018-00500

Details and patient eligibility

About

It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with ASA I-III status ;
• Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion criteria

• Polytrauma patient
• Pregnancy
• Contraindication to spinal anesthesia
• Contraindication to dexamethasone administration
• Patient with chronic pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Intravenous injection of NaCl 0,9% before the surgery.

Treatment:

Drug: NaCl 0.0308 MEQ/ML Injectable Solution