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Block Duration After Spinal Block and iv Dexamethasone.

Primary Purpose

Postoperative Pain, Lower Limb Injury

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone
NaCl 0.0308 MEQ/ML Injectable Solution
Sponsored by
Eric Albrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Duration of sensory block (minutes)
Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached

Secondary Outcome Measures

Highest dermatoma reached (level)
Onset time between injection and highest dermatoma (minutes)
Total duration of the sensory block (minutes)
Total duration of the motor block (minutes)
Time to the first analgesic request (minutes)
Cumulative consumption of morphine (mg)
Pain score
Numeric rating scale (0-10)
Rate of postoperative nausea and vomiting
YES/NO
Rate of pruritus
YES/NO
Rate of urinary retention
YES/NO
Satisfaction level
Numeric rating scale (0-10)
Length of stay
Days
Persistent pain
YES/NO
Pain score if persistent pain
Numeric rating scale (0-10)

Full Information

First Posted
May 4, 2018
Last Updated
July 19, 2022
Sponsor
Eric Albrecht
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1. Study Identification

Unique Protocol Identification Number
NCT03527576
Brief Title
Block Duration After Spinal Block and iv Dexamethasone.
Official Title
Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Albrecht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Lower Limb Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous injection of NaCl 0,9% before the surgery.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Intervention Type
Drug
Intervention Name(s)
NaCl 0.0308 MEQ/ML Injectable Solution
Intervention Description
Intravenous injection of NaCl 0.9% before the surgery.
Primary Outcome Measure Information:
Title
Duration of sensory block (minutes)
Description
Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached
Time Frame
Postoperative day 0
Secondary Outcome Measure Information:
Title
Highest dermatoma reached (level)
Time Frame
Postoperative day 0
Title
Onset time between injection and highest dermatoma (minutes)
Time Frame
Postoperative day 0
Title
Total duration of the sensory block (minutes)
Time Frame
Postoperative day 0
Title
Total duration of the motor block (minutes)
Time Frame
Postoperative day 0
Title
Time to the first analgesic request (minutes)
Time Frame
Postoperative day 0
Title
Cumulative consumption of morphine (mg)
Time Frame
Postoperative days 0, 1 and 2
Title
Pain score
Description
Numeric rating scale (0-10)
Time Frame
Postoperative days 0, 1 and 2
Title
Rate of postoperative nausea and vomiting
Description
YES/NO
Time Frame
Postoperative day 0, 1 and 2
Title
Rate of pruritus
Description
YES/NO
Time Frame
Postoperative day 0, 1 and 2
Title
Rate of urinary retention
Description
YES/NO
Time Frame
Postoperative day 1 and 2
Title
Satisfaction level
Description
Numeric rating scale (0-10)
Time Frame
Postoperative day 2
Title
Length of stay
Description
Days
Time Frame
up to 14 days
Title
Persistent pain
Description
YES/NO
Time Frame
3 and 6 postoperative months
Title
Pain score if persistent pain
Description
Numeric rating scale (0-10)
Time Frame
3 and 6 postoperative months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois and University of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Block Duration After Spinal Block and iv Dexamethasone.

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