Block Duration After Spinal Block and iv Dexamethasone.

Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Lower Limb Injury
• Intervention / Treatment: Drug: Dexamethasone; Drug: NaCl 0.0308 MEQ/ML Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone; Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.	Drug: Dexamethasone; Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
Placebo Comparator: Placebo; Intravenous injection of NaCl 0,9% before the surgery.	Drug: NaCl 0.0308 MEQ/ML Injectable Solution; Intravenous injection of NaCl 0.9% before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperative day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest dermatoma reached (level)		Postoperative day 0
Onset time between injection and highest dermatoma (minutes)		Postoperative day 0
Total duration of the sensory block (minutes)		Postoperative day 0
Total duration of the motor block (minutes)		Postoperative day 0
Time to the first analgesic request (minutes)		Postoperative day 0
Cumulative consumption of morphine (mg)		Postoperative days 0, 1 and 2
Pain score	Numeric rating scale (0-10)	Postoperative days 0, 1 and 2
Rate of postoperative nausea and vomiting	YES/NO	Postoperative day 0, 1 and 2
Rate of pruritus	YES/NO	Postoperative day 0, 1 and 2
Rate of urinary retention	YES/NO	Postoperative day 1 and 2
Satisfaction level	Numeric rating scale (0-10)	Postoperative day 2
Length of stay	Days	up to 14 days
Persistent pain	YES/NO	3 and 6 postoperative months
Pain score if persistent pain	Numeric rating scale (0-10)	3 and 6 postoperative months

Collaborators and Investigators

• Sponsor: Eric Albrecht

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CER 2018-00500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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