Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration
Condition: Fractures, Bone; Nausea and Vomiting, Postoperative; Pruritus; Morphine Adverse Reaction; Satisfaction, Personal
MeSH terms: Pruritus; Nausea; Vomiting; Postoperative Nausea and Vomiting; Fractures, Bone
Intervention: Dexamethasone; Ondansetron; Saline
Intervention description: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.; Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.; Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Intervention MeSH terms: Dexamethasone; Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled, double-blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Group assignments will be sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients will be blinded to group assignments. Study 5-mL syringes will be prepared by a nurse independent of the study. Normal saline (5 mL total volume), dexamethasone (made up to 5 mL with normal saline), or ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened.
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Intrathecal morphine; Nausea and vomiting; Quality of recovery; Patient satisfaction; Pruritus; Postoperative pain

Summary:

      The aim of this study is to evaluate not only the occurrence of side effects, but the quality
      of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with
      administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of
      fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg),
      dexamethasone (8mg) or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA physical status I or II, who will scheduled to undergo surgical treatment of lower
             limb fractures

        Exclusion Criteria:

        Patients who:

        (i) refused to participate in the study;

        (ii) were not able to communicate due to alterations in the level of consciousness, or
        neurologic, or psychiatric disease;

        (iii) presented with contraindication to any of the drugs used in the present study;

        (iv) had history of alcohol or drug abuse and

        (v) had surgery in the last 10 days were excluded.

        Reasons for exclusion after randomisation will be protocol violations or if the anesthesia
        technique was changed from a spinal to a general approach.