Postoperative Pain Clinical Trial
Official title:
Block Duration After Spinal Block and iv Dexamethasone: a Randomized Controlled Double-blinded Trial
Verified date | July 2022 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois and University of Lausanne | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Eric Albrecht |
Switzerland,
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 |
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