Block Duration After Spinal Block and iv Dexamethasone.

Phase 4

Completed

• Conditions: Postoperative Pain; Lower Limb Injury
• Interventions: Drug: NaCl 0.0308 MEQ/ML Injectable Solution; Drug: Dexamethasone

• Registration Number: NCT03527576
• Lead Sponsor: Eric Albrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Primary Completion: 2021-11-01
• Study Completion: 2022-04-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl 0.0308 MEQ/ML Injectable Solution	Intravenous injection of NaCl 0,9% before the surgery.
Dexamethasone	Dexamethasone	Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.

Primary Outcome Measures

Name	Time	Method
Duration of sensory block (minutes)	Postoperative day 0	Time interval between injection of the local anaesthetic and the regression of 2 dermatoma, compared to the highest dermatoma reached

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland