Efficacy of intravenous dexamethasone in prolonging the duration of spinal anesthesia with chloroprocaine in knee arthroscopy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Medico Chirurgical Ambroise Pare Hartmann

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-04-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Secondary objectives 12

1. Time to complete resolution of motor block (Bromage score 0).
2. Time to regression of sensory block by four dermatomes (pin-prick test).
3. Maximum level of sensory block.
4. Time to onset of sensory block.
5. Need for additional anesthetic procedure.
6. Time to regression of sensory block by two dermatomes (cold test).
7. Incidence of adverse events including hypotension, bradycardia, PONV, pruritus, urinary retention.
8. Maximal pain score in the post-anesthesia care unit (PACU) (NRS 0-10).
9. Total opioid consumption (oral morphine equivalents).
10. Pain assessment at rest and during movement (NRS 0-10).
11. Duration of surgery.
12. Incidence of post-puncture headache.

Conditions and MedDRA coding

Knee arthroscopy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years
2. Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery)
3. Signed written informed consent form
4. Affiliation to a social security system
5. Negative pregnancy test on the day of procedure for non-menopausal patients

Exclusion criteria 16

1. 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
2. History of diabetes
3. Pre-existing peripheral neuropathy
4. American Society of Anesthesiologists (ASA) physical status IV
5. Contraindication to dexamethasone including: hypersensitivity to dexamethasone or to any of the excipients; systemic infection; systemic fungal infection; administration of live virus vaccines
6. Hypersensitivity of any drug used in this study
7. Long-term oral corticosteroid therapy
8. Chronic opioid use
9. Chronic pain syndromes
10. 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
11. Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty)
12. Mental or linguistic inability to understand the study
13. Patients under legal protection (guardianship, curatorship or safeguard of justice)
14. Patients currently included or planning to be included in another interventional study
15. Pregnant or breastfeeding women
16. Women of childbearing potential not using effective contraception

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the time to regression of sensory block by two dermatomes, defined as the time (in minutes) from the spinal puncture to the regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed every 5 minutes after spinal puncture using a pin-prick test (0-2: 0 = absent sensation; 1 = dull, decreased sensation; 2 = sharp, normal sensation).

Secondary endpoints 12

1. Time (in minutes) from the spinal puncture to complete recovery of motor block, assessed by the Modified Bromage Scale (0–3: 0 = full flexion of hip, knee, and ankle; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = no movement of hip, knee, or ankle). Motor block will be assessed every 5 minutes after the spinal puncture until regression of the sensory block by two dermatomes, and then every 10 minutes until complete motor recovery (Bromage 0).
2. Time (in minutes) from the spinal puncture to regression of four dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed using the pin-prick test every 5 minutes after the spinal puncture until regression by two dermatomes, and then every 10 minutes until regression by four dermatomes.
3. Highest dermatome level of sensory block achieved after the spinal puncture assessed using the pin-prick test.
4. Time (in minutes) from the spinal puncture to the highest blocked dermatome.
5. Need (or not) for an additional anesthetic procedure (sedation or general anesthesia) will be recorded only in the case of intraoperative pain at the incision site, during surgical manipulation, or during tourniquet inflation. Such cases will be considered as failures of spinal anesthesia. If sedation is administered solely for anxiety in the operating room, preventing further sensory or motor assessment, the patient will be excluded from the per-protocol analysis.
6. Time (in minutes) from the spinal puncture to regression of two dermatomes from the highest dermatome level of sensory block achieved after the puncture, assessed using the cold test. Cold sensation will be evaluated with a stainless-steel cylinder (2–4 °C). The cylinder will be applied gently for 1–2 seconds to each dermatome without pressure. The reference area (T4) will be used to define normal cold sensation.
7. Any episode occurring from spinal puncture up to 24 hours after surgery, including: hypotension, bradycardia, nausea and vomiting, pruritus, urinary retention.
8. Maximal pain score collected in the PACU using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain).
9. Total opioid consumption will be recorded and converted to oral morphine equivalents (OME, mg), including all opioids administered during the intraoperative period, in the PACU, during the ambulatory hospitalization until discharge, as well as those taken at home within 24 hours after surgery, as reported during the follow-up phone call at Day 1 (D1).
10. Pain intensity will be assessed using a Numeric Rating Scale (NRS, 0–10) at rest and during movement, and recorded during the intraoperative period (H0), in the PACU (H1 ± 30min), during the ambulatory hospitalization until discharge (H3 ± 1h and H6 ± 2h), and at home until D1 (H9 ± 2h, H12 ± 2h and H24 ± 3h).
11. Time (in minutes) between the skin incision and the last suture.
12. Post puncture headache (Yes/No) evaluated at D1.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Medico Chirurgical Ambroise Pare Hartmann

Sponsor organisation

Centre Medico Chirurgical Ambroise Pare Hartmann

Address

25 Boulevard Victor Hugo

City

Neuilly-Sur-Seine

Postcode

92200

Country

France

Scientific contact point

Organisation

Centre Medico Chirurgical Ambroise Pare Hartmann

Contact name

Cécile NAUDIN

Public contact point

Organisation

Centre Medico Chirurgical Ambroise Pare Hartmann

Contact name

Cécile NAUDIN

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications