Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy (CHLORODEX)

Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy: a Double-blind, Randomized, Controlled Trial

Chloroprocaine is a short-acting local anesthetic that allows rapid recovery and early ambulation but is currently recommended for procedures lasting 40 minutes or less.

Dexamethasone is commonly used during anesthesia for the prevention of postoperative nausea and vomiting and has also been shown to prolong the duration of analgesia and sensory block after regional anesthesia.

Dexamethasone may therefore extend the duration of chloroprocaine spinal anesthesia, potentially allowing its use for longer surgical procedures while maintaining the benefits of rapid postoperative recovery.

This study aims to evaluate whether intravenous dexamethasone can prolong the effects of spinal anesthesia performed with chloroprocaine in adults undergoing knee arthroscopy.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthroscopy
• Intervention / Treatment: Drug: Sodium Chloride 0.9%; Drug: Chloroprocaine Injection [Clorotekal]; Drug: Dexamethasone

Detailed Description

This is a monocenter, prospective, randomized (1:1 ratio), controlled, parallel-group, double-blind, phase III superiority trial assessing the efficacy and the safety of IV dexamethasone for prolonging sensory block in patients undergoing knee arthroscopy under spinal anesthesia with chloroprocaine.

Participants will be randomly allocated into two groups:

• Group CHLORO (control group): Patients will receive spinal anesthesia with chloroprocaine 40mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes.
• Group CHLORODEX (experimental group): Patients will receive spinal anesthesia with chloroprocaine 40 mg (Clorotekal®10 mg/mL, solution for injection, 4 mL) combined with an IV infusion of dexamethasone at a dose of 0.15 mg/Kg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes.

To ensure blinding, study infusions (saline or dexamethasone) will be prepared in identical 100 mL bags and labelled by a pharmacy staff member or an "outside protocol" healthcare professional (physician or nurse) not involved in patient care or assessment.

The infusion will start approximately 10-15 minutes before the spinal punction.

In the operating room, patients will receive standard perioperative care for spinal anesthesia, including placement of a peripheral intravenous line, supplemental low-flow oxygen therapy to maintain SpO₂ > 93%, continuous hemodynamic monitoring, and strict aseptic precautions. Analgesic premedication with paracetamol combined with either ketoprofen or celecoxib will be administered according to institutional practice.

Spinal anesthesia will be performed with the patient in a semi-sitting position via the L3-L4 or L4-L5 interspace using a 25G x 80mm Sprotte needle. After cerebrospinal fluid reflux, 40 mg of chloroprocaine without adjuvant will be injected intrathecally, and patients will then be positioned in the supine position for the procedure.

Knee arthroscopy will be performed according to standard surgical practice, without any modification of the surgical procedure for study purposes.

No additional sedation or analgesia will be administered during the procedure. In the event of failure of spinal anesthesia or early recovery of sensation, conversion to general anesthesia or deep sedation may be performed at the discretion of the anesthesiologist, depending on the clinical situation.

Postoperatively, multimodal analgesia will be initiated according to the institutional protocol, combining paracetamol, nefopam, and either ketoprofen or celecoxib, with morphine administered if necessary.

Sensory and motor blocks will be assessed every 5 minutes after spinal puncture until regression of two dermatomes and then every 10 minutes until recovery of four dermatomes and complete motor function (maximum until hospital discharge).

Motor block will be assessed using the Bromage score and sensory block will be assessed using the Pin Prick test and the cold test.

The primary objective of the study is to evaluate the efficacy of intravenous dexamethasone in prolonging sensory block following spinal anesthesia with chloroprocaine, as assessed by the time from intrathecal injection to regression of sensory block by two dermatomes from the highest level of sensory block achieved, as measured by the pin-prick test.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sébastien BLOC, MD; Phone Number: 01 44 14 11 11; Email: sebebloc@gmail.com

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75016
      • Clinique Drouot Rémusat
      • Contact: Cyril QUEMENEUR, MD; Phone Number: 01 44 14 11 11; Email: c.quemeneur@gmx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Contraindications to spinal anesthesia with intrathecal chloroprocaine
• History of diabetes,
• Pre-existing peripheral neuropathy,
• American Society of Anesthesiologists (ASA) physical status IV,
• Contraindication to dexamethasone,
• Hypersensitivity of any drug used in this study,
• Long-term oral corticosteroid therapy,
• Chronic opioid use,
• Chronic pain syndromes,
• Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CHLORO; Normal saline solution IV infusion	Drug: Sodium Chloride 0.9%; IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes; Drug: Chloroprocaine Injection [Clorotekal]; Spinal anesthesia with chloroprocaine 40 mg
Experimental: CHLORODEX; Dexamethasone IV infusion	Drug: Chloroprocaine Injection [Clorotekal]; Spinal anesthesia with chloroprocaine 40 mg; Drug: Dexamethasone; IV infusion of dexamethasone at a dose of 0.15 mg/kg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to regression of sensory block by two dermatomes (pin-prick test)	Time (in minutes) from the spinal puncture to the first assessment at which the sensory block has regressed by two dermatomes from the maximum (highest/most cephalad) dermatome level of sensory block achieved after the puncture, assessed with the pin-prick test. Sensory testing will be performed every 5 minutes until two-dermatome regression is observed. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.	Up to 2 hours following spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete resolution of motor block	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).	Up to 8 hours following spinal anesthesia
Time to regression of sensory block by four dermatomes (pin-prick test)	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. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.	Up to 8 hours following spinal anesthesia
Maximum sensory block level	Highest dermatome level of sensory block achieved after the spinal puncture (pin-prick test).	Up to 30 minutes following spinal anesthesia
Time to maximum sensory block level	Time (in minutes) from the spinal puncture to the highest blocked dermatome (pin-prick test).	Up to 30 minutes following spinal anesthesia
Need for additional anesthetic procedure	Whether an additional anesthetic procedure was required during surgery, including sedation or conversion to general anesthesia	From spinal anesthesia to the end of surgery
Time to regression of sensory block by two dermatomes (cold test)	Time (in minutes) from spinal puncture to two dermatome sensory regression assessed by a standardized cold test	Up to 2 hours following spinal anesthesia
Incidence of hypotension	Any episode of hypotension, defined as a systolic blood pressure (SBP) < 90 mmHg and/or a mean arterial pressure (MAP) < 65 mmHg and/or a decrease in blood pressure ≥ 30% from baseline	From spinal anesthesia to 24 hours after surgery
Incidence of bradycardia	Any episode of bradycardia defined as a heart rate (HR) < 50 bpm	From spinal anesthesia to 24 hours after surgery
Incidence of nausea	Any episode of nausea reported by the patient or nursing team	From spinal anesthesia to 24 hours after surgery
Incidence of vomiting	Any episode of vomiting reported by the patient or nursing team	From spinal anesthesia to 24 hours after surgery
Incidence of pruritus	Any episode of pruritus reported by the patient or nursing team	From spinal anesthesia to 24 hours after surgery
Incidence of urinary retention	Any episode of urinary retention reported by the patient or nursing team	From spinal anesthesia to 24 hours after surgery
Maximal pain score in the PACU	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).	Up to 6 hours following spinal anesthesia
Total opioid consumption	Total opioid consumption, converted to oral morphine equivalents (OME, mg) from the intraoperative period to 24 hours postoperatively, including opioid use at home as reported during the Day 1 follow-up	From spinal anesthesia to 24 hours after surgery
Pain intensity	Pain intensity at rest and during movement will be assessed using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain). Pain scores will be recorded intraoperatively (H0)in the PACU (H1), during ambulatory hospitalization (H3 and H6), and at home until Day-1 (H9, H12 and H24).	From spinal anesthesia to 24 hours after surgery
Duration of surgery	Time (in minutes) between the skin incision and the last suture	Intraoperative period
Incidence of post-puncture headache	Any episode of headache reported by the patient or nursing team	From spinal anesthesia to 24 hours after surgery

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: spinal anesthesia; dexamethasone; Knee arthroscopy; chloroprocaine; motor block; sensory block
• Additional Relevant MeSH Terms: Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride; chloroprocaine
• Other Study ID Numbers: 2023/01; 2023-505247-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No