Block Duration After Spinal Block and iv Dexamethasone.

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527576
• Other study ID #: CER 2018-00500
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Injuries
• Lower Limb Injury
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
• NaCl 0.0308 MEQ/ML Injectable Solution
Intravenous injection of NaCl 0.9% before the surgery.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Eric Albrecht

Country where clinical trial is conducted

Switzerland, 

Outcome

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