BridgeMD
Efficacy of intravenous dexamethasone in prolonging the duration of spinal anesthesia with chloroprocaine in knee arthroscopy.
EU CTIS ID: 2023-505247-39-00
What this study is testing
The main objective is to evaluate the efficacy of IV dexamethasone to prolong the sensory block obtained by spinal anesthesia with chloroprocaine, assessed as the time to regression by two dermatomes from the highest blocked dermatome, using the pin-prick method.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery)
- Signed written informed consent form
- Affiliation to a social security system
- Negative pregnancy test on the day of procedure for non-menopausal patients
You likely can't join if
- Contraindications to spinal anesthesia with intrathecal chloroprocaine including: hypersensitivity to chloroprocaine, medicinal products of the para-aminobenzoic acid (PABA) ester group, to other ester-type local anesthetics, or to any of the excipients; general and specific contraindications to spinal anesthesia regardless of the local anesthetic used (e.g. decompensated cardiac insufficiency, hypovolemic shock, severe hypovolemia, coagulopathy); intravenous regional anesthesia; serious problems with cardiac conduction; severe anemia; local infection at the puncture site or systemic infection/sepsis
- Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) including: history of hypersensitivity reactions after administration of ketoprofen, celecoxib, aspirin or other NSAIDs (including bronchospasm/asthma, rhinitis, urticaria, angioedema, anaphylaxis); active peptic ulcer disease or active gastrointestinal bleeding; history of recurrent peptic ulcer/hemorrhage; history of gastrointestinal bleeding/ulceration/perforation related to NSAID therapy; severe renal impairment; severe hepatic impairment; severe heart failure; and for celecoxib specifically: known hypersensitivity to sulfonamides; established ischemic heart disease and/or peripheral arterial disease and/or cerebrovascular disease
- Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty)
- Mental or linguistic inability to understand the study
- Patients under legal protection (guardianship, curatorship or safeguard of justice)
- Patients currently included or planning to be included in another interventional study
See the full eligibility criteria
- Age ≥ 18 years
- Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery)
- Signed written informed consent form
- Affiliation to a social security system
- Negative pregnancy test on the day of procedure for non-menopausal patients
- Contraindications to spinal anesthesia with intrathecal chloroprocaine including: hypersensitivity to chloroprocaine, medicinal products of the para-aminobenzoic acid (PABA) ester group, to other ester-type local anesthetics, or to any of the excipients; general and specific contraindications to spinal anesthesia regardless of the local anesthetic used (e.g. decompensated cardiac insufficiency, hypovolemic shock, severe hypovolemia, coagulopathy); intravenous regional anesthesia; serious problems with cardiac conduction; severe anemia; local infection at the puncture site or systemic infection/sepsis
- Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib) including: history of hypersensitivity reactions after administration of ketoprofen, celecoxib, aspirin or other NSAIDs (including bronchospasm/asthma, rhinitis, urticaria, angioedema, anaphylaxis); active peptic ulcer disease or active gastrointestinal bleeding; history of recurrent peptic ulcer/hemorrhage; history of gastrointestinal bleeding/ulceration/perforation related to NSAID therapy; severe renal impairment; severe hepatic impairment; severe heart failure; and for celecoxib specifically: known hypersensitivity to sulfonamides; established ischemic heart disease and/or peripheral arterial disease and/or cerebrovascular disease
- Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty)
- Mental or linguistic inability to understand the study
- Patients under legal protection (guardianship, curatorship or safeguard of justice)
- Patients currently included or planning to be included in another interventional study
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception
- History of diabetes
- Pre-existing peripheral neuropathy
- American Society of Anesthesiologists (ASA) physical status IV
- Contraindication to dexamethasone including: hypersensitivity to dexamethasone or to any of the excipients; systemic infection; systemic fungal infection; administration of live virus vaccines
- Hypersensitivity of any drug used in this study
- Long-term oral corticosteroid therapy
- Chronic opioid use
- Chronic pain syndromes
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.