Block Duration After Spinal Block and iv Dexamethasone.

E

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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